CENTER FOR DRUG EVALUATION AND RESEARCH · 2020-01-30 · Center for Drug Evaluation and Research Oﬃce of Translational Sciences Oﬃce of Biostatistics Division of Biometrics VI

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

761086Orig1s000

PRODUCT QUALITY REVIEW(S)

US Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and ResearchOffice of Translational SciencesOffice of BiostatisticsDivision of Biometrics VI

STATISTICAL REVIEW AND EVALUATION

BLA NO. 761086DATE RECEIVED BY THE CENTER 12/14/2018DRUG NAME ABP 710

DOSAGE FORMA sterile, preservative-free, white to slightly yellow,lyophilized powder in a single-use vial for intravenousinfusion

INDICATION The same as Remicade (infliximab)SPONSOR AmgenREVIEW FINISHED 5/6/2019STATISTICAL REVIEWER Chao Wang, Ph.D.SECONDARY REVIEWER Meiyu Shen, Ph.D.PROJECT MANAGER Christine Ford

Chao Wang, Ph.D., Mathematical Statistician, CDER/OTS/OB/DBVIMeiyu Shen, PhD., Lead Mathematical Statistician, CDER/OTS/OB/DBVI

Concur:Stella Grosser, Ph.D., Division Director, CDER/OTS/OB/DBVIII

CC List:Yi Tsong, Ph.D., Division Director, CDER/OTS/OB/DBVIChristine Ford, CDER/OND/ODEII/DPARP

Reference ID: 4512223

Statistical Review of BLA 761086

Contents

1 Executive summary and recommendation 2

2 Introduction 2

3 The FDA Statistical reviewer’s analysis 23.1 The equivalence test method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23.2 Data quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.2.1 ABP 710 Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43.2.2 Infliximab Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.3 Equivalence test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43.3.1 Relative potency through inhibition of sTNFα-induced Apoptosis in U937 . . . . . . . 43.3.2 sTNFα binding by ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4 Conclusion and recommendations 6

Reference 6

Page 1 of 6


Statistical Review of BLA 761086 3 THE FDA STATISTICAL REVIEWER’S ANALYSIS

1 Executive summary and recommendation

In this evaluation I reviewed the data and analyzed the similarity of two Tier 1 quality attributes, RelativePotency and sTNFα Binding by ELISA for ABP 710 compared with US-licensed Remicade, submitted byAmgen. There are no significant issues with the data quality.

My independent analysis showed that both attributes pass the statistical equivalence test and support ademonstration that ABP 710 is highly similar to US-licensed Remicade.

2 Introduction

On 12/14/2018, Amgen submitted to the U.S. Food and Drug Administration (FDA) a 351(k) BLA whichincluded an analytical similarity assessment, comparing two Tier 1 quality attributes for ABP 710 withUS-licensed Remicade. Below, I reviewed the data quality and evaludated the similarity of the two attributes.

3 The FDA Statistical reviewer’s analysis

3.1 The equivalence test method

In this review, I used the equivalence test method used by the applicant, which was discussed and agreedduring previous meetings between the applicant and the FDA. Below, I briefly discussed the method.

Tn equivalence test concerns testing the means of two normal distributions for Tier 1 QAs between a proposedbiosimilar product (B) and a reference product (R). To test the equivalence in mean, the null and alternativehypotheses are formulated as follows:

H0 : μB − μR ≤ −δ or μB − μR ≥ δ,

andHa : −δ < μB − μR < δ,

where μB and μR are the mean responses of the proposed biosimilar and reference product lots, respectively,and δ > 0 is the equivalence margin which will be specified later.

A test of the equivalence hypothesis can be conducted by requiring simultaneous rejection of the followingtwo one-sided null hypotheses:

H10 : μB − μR ≤ −δ versus H1a : μB − μR > −δ,

andH20 : μB − μR ≥ δ versus H2a : μB − μR < δ.

Let (XB,j , j = 1, · · · , nB) and (XR,j , j = 1, · · · , nR) be the two samples for the proposed biosimilar andreference product of sample size nB and nR respectively. It is assumed that for I = B, R, XI,j ∼IID N(μI , σ2

I )are independent and identically distributed (IID) as a normal distribution with mean μI and standard deviationσI > 0 .

Page 2 of 6



In practice, XI,j represents the lot value, calculated as the sample mean of multiple replicated measurementsfor each drug product lot j of drug I. While there is no consensus on how many within-lot replicates shouldbe used, it is known that under independent sampling, the more number of replicates are collected for eachlot, the less the variability of lot-average will be.

It is also generally required that the same number of within-lot replicates should be obtained for all drug lotsfor both test and reference drug products, due to the following reasons. Note that in Tier 1 equivalence testfor each drug product (DP) lot, the within-DP lot average is used, whose variance is a function of the numberof within-DP lot replicates used in computing the average. Assume that YI,j,k is the measured value for aQA from the k-th replicate from j-th DP lot for drug I, and YI,j,k = μ + rj + εj,k, with rj ∼IID N(0, σ2

dp)and εj,k ∼IID N(0, σ2

ε ) and rj and εj,k are mutually independent. Since XI,j = 1K

∑Kk=1 YI,j,k, var(XI,j) =

σ2dp + σ2

ε /K. Different number of within-lot replicates can lead to violation of IID assumption for lot valueXI,j , I = B, R, j = 1, · · · , nI , used in the equivalence test.

Let μI and σ2I be the sample mean and unbiased sample variance estimates respectively for I = B, R. The

test statistics for the two one sided tests H1 and H2 are defined respectively as

τ1 =μB − μR + δ√

σ2B/n∗

B + σ2R/n∗

R

,

andτ2 =

μB − μR − δ√σ2

B/n∗B + σ2

R/n∗R

,

where n∗B = min{1.5nR, nB} and n∗

R = min{1.5nB , nR} are the adjusted sample sizes (Dong, Weng, andTsong 2017). Then H10 is rejected if τ1 > t1−α,df∗ and H20 is rejected if τ2 < tα,df∗ , where tα,df∗ is α-thupper quantile of the t-distribution with degree of freedom df∗, which is approximated by the Satterthwaitemethod with sample size adjusted and given as follows,

df∗ =

(σ2

B

n∗B

+ σ2R

n∗R

)2

1nB−1

(σ2

B

n∗B

)2+ 1

nR−1

(σ2

R

n∗R

)2 .

Equivalently, equivalence is accepted for the quality attribute if the following 100(1 − 2α)% two-sidedconfidence interval (CI) of the mean difference is within (−δ, δ),

(μB − μR − t1−α,df∗

√σ2

B/n∗B + σ2

R/n∗R, μB − μR + t1−α,df∗

√σ2

B/n∗B + σ2

R/n∗R

).

The equivalence margin is set as δ = cσR, where c is the margin multiplier and is recommended to be 1.5(Tsong, Dong, and Shen 2017). In this case, the test would yield a positive result if the 90% confidenceinterval about the difference in sample means lies within (−1.5σR, 1.5σR). For known σR, if there were 10biosimilar and 10 reference product lots, this test would have adequate power (at least 85%) to reject the nullhypothesis in favor of equivalence when the true underlying mean difference between the proposed biosimilarand reference product lots is equal to σR/8, assuming a test with α = 0.05. If the true difference betweenproducts is less than σR/8, the power will increase. In practice, σR in the proposed margin is unknown andestimated by the sample standard deviation of reference product lots estimated from the reference productlots available to the biosimilar applicant.

In the following analysis, the nominal size is set as α = 0.05.

Page 3 of 6



3.2 Data quality

3.2.1 ABP 710 Lots

The applicant included all ABP 710 drug product lots that were used in clinical studies in the similarityassessment. The applicant included the lots for the similarity assessment based on the following considerations:

• For parameters primarily influenced by the drug substance manufacturing process (eg, glycan profileand potency), each unique drug substance lot is represented once in the similarity assessment. A totalof 14 ABP 710 drug substance lots were included in the similarity assessment represented by 12 drugproduct lots and 2 drug substance lots. The 2 drug substance lots were not filled into drug product andwere therefore assessed directly. The ABP 710 drug substance lots include development lots, all lotsused in clinical studies, and process validation lots.

• For parameters primarily influenced by the drug product manufacturing process (eg, protein contentand reconstitution time), a total of 19 drug product lots were included in the analytical similarityassessment. This encompasses all lots used in clinical studies and 3 drug product process validation lots.

• For stability-indicating attributes (ie, product-related substances and impurities), drug product stabilitydata were used to determine the product degradation rate. Stability-indicating assays showed nopractically significant change at the recommended storage condition over the shelf life of the product;hence age-adjustment on the product quality attributes was not performed.

3.2.2 Infliximab Lots

The applicant sourced US-Remicade on a regular basis, over a period of approximately 6 years. A totalof 28 US-Remicade were tested. The US-Remicade lots were evaluated as part of the analytical similarityassessment. For parameters expected to change as a function of time at their recommended storage condition,available infliximab lots were tested upon receipt and again at or near the end of shelf life. Note that all28 US-Remicade lots were tested for Relative Potency. However, only 25 US-Remicade lots were tested forsTNFα Binding by ELISA. The applicant stated that three US-Remicade lots were not tested due to acombination of assay development timing and/or exhaustion of reference product sample.

3.3 Equivalence test results

3.3.1 Relative potency through inhibition of sTNFα-induced Apoptosis in U937

For Relative Potency, the data are illustrated in Figure 1 and the equivalence test result is summarized inTable 1, which shows that Relative Potency passed the equivalence test.

Page 4 of 6



Table 1: Summary of equivalence test for Relative Potency (%) between ABP 710 and US-Remicade.

Product # of Lots Range Mean Std. Dev. Mean Diff. (90% CI) Margin Pass ET?

ABP 710 14 (87-112) 100 6.8

US-Remicade 28 (78-117) 102 9.1-2.64 (-7.2, 1.91) (-13.67,13.67) Yes

8090

100

110

Rel

ativ

e Po

tenc

y (%

)

ABP 710 US−Remicade

Figure 1: Scatter plot for Relative Potency.

3.3.2 sTNFα binding by ELISA

For sTNFα Binding by ELISA, the data are illustrated in Figure 2 and the equivalence test result issummarized in Table 2, which shows that sTNFα Binding by ELISA passed the equivalence test.

Page 5 of 6


Statistical Review of BLA 761086 4 CONCLUSION AND RECOMMENDATIONS

Table 2: Summary of equivalence test for sTNFα Binding by ELISA (%) between ABP 710 and US-Remicade.

Product # of Lots Range Mean Std. Dev. Mean Diff. (90% CI) Margin Pass ET?

ABP 710 14 (88-109) 100 5.1

US-Remicade 25 (88-112) 98 5.21.39 (-1.6, 4.39) (-7.8,7.8) Yes

9095

100

105

110

sTN

F

ABP 710 US−Remicade

Figure 2: Scatter plot for sTNFα Binding by ELISA.

4 Conclusion and recommendations

In summary, I evaluated the data quality and similarity of two attributes, Relative Potency and sTNFα

Binding by ELISA. There are no significant issues with the data quality and both attributes passed theequivalence test. This evaluation supports the demonstration that ABP 710 is highly similar to US-licensedRemicade.

Reference

Dong, Xiaoyu, Yu-Ting Weng, and Yi Tsong. 2017. “Adjustment for Unbalanced Sample Size for AnalyticalBiosimilar Equivalence Assessment.” Journal of Biopharmaceutical Statistics 27 (2). Taylor & Francis:220–32.

Tsong, Yi, Xiaoyu Dong, and Meiyu Shen. 2017. “Development of Statistical Methods for AnalyticalSimilarity Assessment.” Journal of Biopharmaceutical Statistics 27 (2). Taylor & Francis: 197–205.

Page 6 of 6


--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically. Following this are manifestations of any and allelectronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------

CHAO WANG10/28/2019 03:31:42 PM

MEIYU SHEN10/28/2019 09:22:23 PM

STELLA C GROSSER11/01/2019 05:14:38 PM

Signature Page 1 of 1


For use with OPQ-OBP-SOP-3104: OPQ-OBP-TEM-0010-01 [BLA executive summary annotated template]Page 1 of 23

Department of Health and Human ServicesFood and Drug Administration

Center for Drug Evaluation and ResearchOffice of Biotechnology Products

First Approval for Indication/First Biosimilar/Expedited or Breakthrough Review: No

Recommendation: BLA Approval

BLA Number: 761086Review Number: 1Review Date: 08/14/2019

Drug Name/Dosage Form

Avsola—infliximab-axxq; ABP 710/lyophilized powder for injection

Strength/Potency 100 mg of lyophilized powder in a 20 mL vial to be reconstituted in 10 mL of sterile water for injection

Route of Administration Intravenous infusionRx/OTC dispensed RxIndication All indications for US-licensed RemicadeApplicant/Sponsor AmgenUS agent, if applicable n/a

Product OverviewAvsola (ABP 710) is a chimeric IgG1κ monoclonal antibody proposed as a biosimilar to US-licensed Remicade. Avsola is supplied as a sterile, white lyophilized powder for intravenous infusion, following reconstitution with 10 mL of sterile Water for Injection.

Quality Review Team

Discipline Reviewer Branch/DivisionDrug Substance Yetao Jin OPQ/OBP/DBRR IIDrug Product Bruce Huang OPQ/OBP/DBRR IIImmunogenicity Bruce Huang OPQ/OBP/DBRR IILabeling Scott Dallas OPQ/OBPFacility Ziyang Su OPQ/OPF/DIAMicrobiology Max Van Tassell OPQ/OPF/DMAFacility Team Lead Peter Qiu OPQ/OPF/DIAMicrobiology Team Lead Reyes Candau-Chacon OPQ/OPF/DMARegulatory Business Project Manager

Oumou Barry OPQ/OPRO/DRBPMI/RBPMBI

Application Team Lead Yanming An OPQ/OBP/DBRR IIOBP Tertiary Reviewer Xianghong Jing OPQ/OBP/DBRR II

Mutidisciplinary Review Team:

Discipline Reviewer Office/DivisionRPM Christine Ford ODEII/DPARPCross-disciplinary Team Lead Nikolay Nikolov ODEII/DPARPMedical Officer Katherine Clarridge / Stacy Chin ODEII/DPARP





Pharm/Tox Lawrence Leshin / Carol Galvis ODEII/DPARPClinical Pharmacology Dipak Pisal / Anshu Marathe OCP/DCPIStatistics James Travis / Lei Nie OB/DB VCMC Statistics Chao Wang / Meiyu Shen OB/DB IV

1. Names: a. Proprietary Name: ABP 710b. Trade Name: Avsolac. Non-Proprietary/USAN: infliximab-axxqd. INN Name: pendinge. CAS Registry Number: 1446410-97-4f. OBP systematic name: MAB CHIMERIC (IGG1) ANTI P01375 (TNFA_HUMAN) [ABP 710]

Submissions Reviewed:

Submission(s) Reviewed Document Date761086/0001 12/14/2018761086/0007 (response to DMA IR on 03/26/2019) 04/10/2019761086/0008 (response to OBP IR on 04/11/2019) 04/25/2019761086/0010 (response to DIA IR on 05/09/2019) 05/16/2019761086/0012 (response to CMC Stats IR on 05/20/2019) 05/31/2019761086/0013 (response to OBP IR on 05/21/2019) 06/04/2019761086/0015 (response to DMA IR on 06/19/2019) 06/28/2019761086/0016 (response to OBP & DMA IR on 07/19/2019) 08/01/2019761086/0017 (response to OBP IR on 08/02/2019) 08/07/2019761086/0019 (response to DMA IR on 07/19/2019) 09/18/2019761086/0020 (response to OBP IR on 10/03/2019) 10/10/2019

Quality Review Data Sheet

1. Legal Basis for Submission: 351(k)

2. Related/Supporting Documents:

A. DMFs:

DMF # DMF Type

DMF Holder Item referenced

Code1 Status2 Date Review Completed

3 2 Adequate N/A3 2 Adequate N/A


(b) (4) (b) (4)




5 2 Adequate N/A

1. Action codes for DMF Table: 1- DMF Reviewed; Other codes indicate why the DMF was not reviewed, as follows: 2- Reviewed previously and no revision since last review; 3- Sufficient information in application; 4- Authority to reference not granted; 5- DMF not available; 6- Other (explain under “comments”)

2. Adequate, Adequate with Information Request, Deficient, or N/A (There is not enough data in the application; therefore, the DMF did not need to be reviewed.

B. Other documents: IND, Referenced Listed Drug (RLD), or sister application.

Document Application Number DescriptionIND 122136 Amgen-sponsored IND under which ABP 710

was developed and BPD meetings were held

3. Consults: None.


(b) (4) (b) (4)




Executive Summary

I. Recommendations:

A. Recommendation and Conclusion on Approvability:

The Office of Product Quality (OPQ), CDER, recommends approval of BLA 761086 for ABP 710 manufactured by Amgen, Inc. The data submitted in this application, including the analytical similarity assessment, are adequate to support the conclusion that:

• The manufacture of ABP 710 is well-controlled and leads to a product that is pure and potent;

• ABP 710 is similar to US-licensed Remicade notwithstanding minor differences in clinically inactive components.

It is recommended that this product be approved for human use under conditions specified in the package insert.

B. Approval Action Letter Language:

• Manufacturing location:o Drug Substance:

Immunex Rhode Island Corporation (Referred to as Amgen Rhode Island or ARI) 40 Technology Way,West Greenwich, Rhode Island 02817USAFEI: 3003359885

o Drug Product:

• Fill size and dosage form:100 mg lyophilized solid in a single-use 20 mL vial to be reconstituted with 10 mL sterile water for injection

• Dating period:o Drug Product: 48 months: 2 to 8 °Co Drug Substance: months: °Co For packaged products: “Not packaged” o Stability Option:

We have approved the stability protocol(s) in your license application for the purpose of extending the expiration dating of your drug substance and drug product under 21 CFR 601.12.

• Exempt from lot releaseo Yes


(b) (4)

(b) (4)

(b) (4)




o Rationale, if exempted: Per FR notice 95-29960 well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products are exempt from 21 CFR 601.2a lot release requirement.

• Amgen claimed a categorical exclusion from the preparation of an environmental assessment for ABP 710 in accordance with 21 CFR 25.31 (c). The claim is because ABP 710 is considered “naturally occurring in the environment” and, when exposed to the environment, is not expected to significantly alter the concentration of the substance, its metabolites, or degradation products in the environment. No extraordinary circumstances exist.The claim of a categorical exclusion is accepted.

C. Assessment Summary:

ABP 710 is a proposed biosimilar to US-licensed Remicade. ABP 710 has the same dosage form and route of administration as US-licensed Remicade. Amgen seeks licensure for the following indications:

• Crohn’s Disease (CD)• Pediatric CD (6 years of age and older)• Ulcerative Colitis (UC)• Pediatric UC (6 years of age and older)• Rheumatoid Arthritis (RA)

o In combination with methotrexate (MTX)• Ankylosing Spondylitis (AS)• Psoriatic Arthritis (PsA)• Plaque Psoriasis (Ps)

The overall control strategy includes control of raw materials, facilities and equipment,manufacturing process, and adventitious agents. The control strategy combined with in-process, release, and stability testing ensure that the drug substance and drug product manufacturing processes are well controlled and lead to a product with the expected quality attributes and free of adventitious agents.

The data support the demonstration that ABP 710 is highly similar to US-Remicade, notwithstanding minor differences in clinically inactive components (refer to Section II of this memo for further details and discussion of the differences observed).

Analytical similarity between ABP 710 and US-Remicade was evaluated using a comprehensive array of analytical methods that were suitable to evaluate critical quality attributes of ABP 710 and US-Remicade. The numbers of lots tested and the statistical analyses were appropriate to allow for a meaningful evaluation of the results of the analytical studies.

EU-approved Remicade was not used as a comparator in the clinical studies. The analytical testing results from EU-approved Remicade submitted in the BLA were not assessed and the scientific bridging to US-licensed Remicade is deemed not necessary.





ABP 710 has the same dosage form, formulation, and route of administration as US-licensed Remicade, but has a different formulation. Comparative protein concentration (mg/mL) was assessed as part of the analytical similarity assessment. The deliverable volume (mL) and fill weight data were assessed The proposed presentations of ABP 710 have the same total content of drug substance in units of mass in a container as U.S-licensed Remicade (100 mg/vial). The strength of ABP 710 (100 mg lyophilized powder in vial) is the same as that of US-Humira.

The microbial control and sterility assurance strategy is sufficient to support consistent manufacture of a sterile product. The BLA is recommended for approval from a sterility assurance and microbiology product quality perspective.

The DIA assessor is recommending approval of Immunex Rhode Island Corporation(Referred to as Amgen Rhode Island or ARI) Rhode Island, United States, FEI 3003359885, for commercial manufacture of ABP 710 DS

The OBP assessments including DS, DP, analytical similarity and validation of immunogenicity assays, DMA DS and DP microbiological assessments, and DIA facility technical assessment are located as separate documents in Panorama.

D. Recommendation on Phase 4 (Post-Marketing) Commitments, Requirements, Agreements, and/or Risk Management Steps, if approvable:

1. Develop and implement a control strategy for the Fc-domain-mediated effector function of antibody-dependent cell mediated cytotoxicity (ADCC) of ABP 710. The test format can either be a functional bioassay or the use of FcγRIIIa binding as a surrogate. The proposed control strategy and supporting validation data will be submitted to FDA following 21 CFR 601.12 (b).

II. Comparative Analytical Assessment and Evaluation of the Analytical Component of the Scientific Bridge

A. Analytical Assessment Overview and ConclusionsThe comparative analytical assessment between ABP 710 and US-licensed Remicade compared 19 lots of ABP 710 and 28 lots of US-licensed Remicade. The 19 ABP 710 lots included 17 drug product lots derived from 12 drug substance lots and 2 drug substance lots. Therefore, only 14 ABP 710 lots are considered independent lots. Data generated from studies using EU-approved Remicade were not used to support a demonstration of biosimilarity. Therefore, the analytical testing results from 20 lots of EU-approved Remicade submitted in the BLA were not assessed, as there was no need to establish an adequate scientific bridge.

Amgen used an acceptable risk-based approach for statistical evaluation of analytical results. Highest-ranked risk attributes tested using quantitative assays were evaluated using equivalence testing.


(b) (4)

(b) (4)




Moderate to high risk attributes tested using quantitative assays were evaluated using quality ranges calculated to account for reference product manufacturing variability and assay variability. Low risk attributes or attributes tested using qualitative assays were evaluated using visual display comparisons. The data analysis strategy used by Amgen is consistent with the recommendations FDA provided during product development. Results from method validation or qualification studies support the suitability of the methods used in the comparative analytical assessment.

The expiry dates of the US-licensed Remicade lots range from February 2015 to February 2020. The applicant tested US-licensed Remicade lots upon receipt and again at or near the end of shelf life for attributes expected to change over time at the recommended storage condition. Since no significant change over shelf life was observed, the initial time point testing results were used in the comparative analytical assessment.

The applicant also provided a comparison of stability under thermal forced degradation conditions of 40°C for the lyophilized and reconstituted products and accelerated conditions of 25°C for the lyophilized products.

Based on our assessment of the ABP 710 and US-licensed Remicade data, we determined that ABP 710 has been demonstrated to be highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components. ABP 710 has the same strength, dosage form, presentation, and route of administration as US-licensed Remicade. The applicant used a comprehensive array of analytical methods that were suitable to evaluate critical quality attributes of ABP 710 and US-licensed Remicade to support the demonstration that the products are highly similar. Numbers of lots tested and statistical analyses were appropriate to allow for a meaningful evaluation of the results of the comparative analytical studies. Observed differences do not preclude a demonstration that ABP 710 and US-licensed Remicade are highly similar.

B. Results of Comparative Analytical Assessment

The results of these analytical comparisons support a demonstration that ABP 710 is highly similar to US-licensed Remicade and the results are summarized in Table A below:

Table A. Quality Attributes Analyzed to Support a Demonstration of Highly SimilarPhysico-chemical/Functional Characteristics

Quality Attribute AssessedSupports a Demonstration of Highly Similar

Molecular weight (intact and reduced and deglycosylated of HC and LC)

Yes

Amino acid sequence YesMethionine oxidation Yes*Asparagine deamidation Yes*Disulfide mapping YesIsoelectric point Yes

Primary Structure

Identity by ELISA Yes Afucosylation Yes GlycosylationHigh mannose Yes





Physico-chemical/Functional Characteristics


Β-galactosylation Yes α-galactosylation Yes*Sialyation Yes*Secondary Structure (FTIR) YesTertiary Structure (near UV CD) Yes

Higher Order Structure

DSC Tm1 and Tm2 YesHMW (SE-UHPLC) Yes*Main peak (SE-UHPLC) Yes*LMW (SE-UHPLC) YesMonomer and HMW (SV-AUC) YesMolar mass: main peak and HMW (SE-HPLC-SLS) YesHC + LC (rCE-SDS) Yes*LMW + MMW (rCE-SDS) Yes*NGHC (rCE-SDS) Yes*HMW (rCE-SDS) Yes Pre-peak (nrCE-SDS) Yes*Main peak (nrCE-SDS) Yes*Post-peaks (nrCE-SDS) Yes Main peak (CEX-HPLC) YesAcidic peak (CEX-HPLC) Yes*Basic peak (CEX-HPLC) Yes*

Product-related substances and impurities

Profile treated with carboxypeptidase B Yes Tumor neutralizing factor (TNF)-alpha neutralization (inhibition of sTNFα-induced apoptosis in U937 cells)

Yes

Binding to sTNFα by ELISA YesBinding to sTNFα by SPR by SPR YesBinding kinetics to sTNFα Yes Inhibition of sTNFα-induced IL-8 release in HUVEC Yes Inhibition of sTNFα-induced cell death in L929 YesBinding to mbTNFα by imaging cytometry YesReverse signaling YesBinding to LTα by SPR YesInhibition of LTα -induced IL-8 release in HUVEC YesBinding to FcγRIIIa (158V and 158F) by SPR Yes Binding kinetics to FcγRIIIa (158V) by SPR /Kd (nM) YesBinding to primary NK cells by FACS Yes Antibody-dependent cell-mediated cytotoxicity (ADCC) NK92 cell

Yes

PBMC ADCC activity Yes Binding to C1q by ELISA YesComplement dependent cytotoxicity (CDC) activity YesBinding to FcγRIIa (131R) by SPR YesADCP activity YesBinding to FcγRIa by AlphaLISA YesBinding to FcγRIIb and FcγRIIIb by SPR YesBinding to FcRn by AlphaScreen Yes

Bioactivity

Binding to FcRn by SPR YesDrug Product Attributes Protein content (UV absorbance) Yes





Physico-chemical/Functional Characteristics


Reconstituted protein concentration YesReconstitution time Yes

* Differences between ABP 710 and US-licensed Remicade were noted. However, these differences do not preclude a demonstration of highly similar. See section IV for additional information.

sTNFα binding and neutralization of sTNFα-induced apoptosis are generally regarded as the main mechanism of action for infliximab products. Two assays were conducted to probe these activities and the results were analyzed by equivalence testing. For the inhibition of sTNFα-induced apoptosis assay, the applicant provided data from 14 lots of ABP 710 and 28 lots of US-licensed Remicade. For the TNF-α binding assay by ELISA, the applicant provided data from 14 lots of ABP 710 and 25 lots of US-licensed Remicade. OBP reviewed the justification of lots selection and concluded that the lots selected for each product were representative. The CMC Statistics reviewer assessed statistical equivalence testing and determined that the data met the equivalence margins for both assays, supporting a demonstration that ABP 710 is highly similar to US-licensed Remicade.

Additional potential mechanisms of action have been proposed for infliximab products in the scientific literature. These include antibody dependent cell-mediated cytotoxicity against cells expressing membrane-bound TNF-α (mTNF-α), complement dependent cytotoxicity against mTNF-α positive cells, “reverse signaling” (signal transduction into cells by activation of mTNF-α), and induction of regulatory macrophages. It is likely that the relative role for each of these mechanisms differs between indications. Assays that are orthogonal to the sTNFα binding and the neutralization assays, assays that evaluate these additional potential mechanisms of action, and assays that evaluate purity, protein content, and other general properties of infliximab products were assigned for quality range or visual comparison assessment.

The protein biochemistry and biological activity attributes tested in Table A met the pre-defined comparative analytical acceptance criteria in the comparison of ABP 710 to US-licensed Remicade with exceptions discussed in Section D of this memo. The testing results from the comparison of the stability under stressed and accelerated conditions indicated that the stability of ABP 710 drug product and US-licensed Remicade are similar and any differences do not preclude a demonstration that ABP 710 is highly similar to US-licensed Remicade.

C. Analytical Studies to Support the Use of a Non-U.S.-Licensed Comparator Product

Not applicable.

D. Assessment of Comparative Analytical Study Results

Comparative analytical acceptance criteria were met for all attributes with the following exceptions:• All ABP 710 lots have higher high molecular weight (HMW) levels (0.7-1.3%) than the quality

ranges of US-licensed Remicade (0.1-0.4%). And the corresponding main peak levels (98.6-99.2%) are lower than the quality ranges of US-licensed Remicade (99.4-99.9%). The HMW fraction was characterized as predominantly non-covalent dimer (~60-86%). Non-covalent





dimers are reversible and may dissociate in vivo, making this already small difference effectively negligible. Difference in HMW species may impact product bioactivity. To evaluate whether the difference in HMW species impacted bioactivity, the HMW species fractions were isolated and their bioactivity was measured using cell-based potency assays for TNF-α neutralization and ADCC. The HMW fraction showed comparable bioactivity to the main peak in both the TNF-α neutralization assay and ADCC assay. TNF-α neutralization is the primary mechanism of action (MoA) of infliximab across all indications. ADCC activity is a potential MoA for certain indications. TNF-α neutralization assay and ADCC assay measure both bioactivities which are clinically relevant and are suitably representative of the drug’s MoAs for this analysis. The total level of HMW species is low and the applicant proposed to control the levels of Main peak and HMW species for DS and DP release and stability. Based on the HMW species characterization study and the acceptable control strategy, the observed differences in HMW species do not preclude a demonstration of highly similar.

• The levels of size variants measured by rCE-SDS are out of the quality ranges of US-licensed Remicade as follows: 1) HC+LC% range (96.6-97.3%) is below the quality range of 98.3-99.1%; 2) LMW+MMW% range (0.7-1.0%) is slightly higher than quality range of 0.1-0.9%; 3) non-glycosylated heavy chain (NGHC%) range (1.6-2.1%) is higher than quality range of 0.4-0.6%. The LMW/MMW species are primarily fragments. The fragments and NGHC may have different biological activity compared with intact molecules. The bioactivity testing on the LMW/MMW fraction did not show any impact on the biological activity. The NGHC fraction was also tested for bioactivity and the results indicated the product biological activity was not impacted by the higher level of NGHC.

The %pre-peak (1.8-2.6) and % main peak (97.1-98.1%) measured by nrCE-SDS are out of the quality ranges of US-licensed Remicade of 0.7-2.1% and 97.8-99.3%, respectively. The difference for each attribute compared to the quality range was less than 1%. As characterized for the low molecular weight fractions in rCE-SDS, the minor differences did not impact biological activity and the levels of fragments have been controlled by controlling the levels of monomer and HMW at release and on stability. Therefore, the differences the levels of fragments observed in the rCE-SDS and nrCE-SDS assays do not preclude a demonstration of highly similar.

• The % basic peak in 7 out of 12 ABP 710 lots (30.0-36.1%) was below the quality ranges of US-licensed Remicade (32.3-60.2%). The carboxypeptidase B treatment study indicated that the basic species are the variant with C-terminal lysine. Since the C-terminal lysine will be immediately cleaved in vivo, it is not considered a critical quality attribute and bioactivity testing (TNF-α neutralization assay and ADCC assay) on the basic peak fraction did not show any impact on the biological functions representative of the product’s MoA.

The %acidic peak in all batches of ABP 710 (19.5-23.6%) was above the quality ranges of US- licensed Remicade (8.4-17.8%). Characterization study of the ABP 710 acidic peak fractions showed that deamidation at HC CDR2 Asn57 is higher in ABP 710 than US-licensed Remicade. Higher level of deamidation at the CDR may impact the protein bioactivity. The bioactivity of the purified acidic fractions from both products were tested using TNF-α neutralization assay and ADCC assay and the results demonstrated the acidic fractions have similar bioactivity to the main peak. The charge variants and post-translational modification differences observed between ABP 710 and US-licensed Remicade did not result in biological activity differences. Therefore, the differences noted in basic and acidic species do not preclude a demonstration of highly similar.





• US-licensed Remicade has low level of α-galactosylation (< 6.6%), which was not detected in ABP 710. US-licensed Remicade is produced in SP2/0 cells which express low level of terminal α-galactose. ABP 710 is produced in CHO cells which do not express terminal α-galactose. Increased galactosylation may increase C1q binding and CDC activity. However, this difference in α-galactosylation did not result in differences in CDC activity or C1q binding. Therefore, the observed differences in galactosylation do not preclude a demonstration of highly similar.

• Of the trace levels of sialylated glycans detected, N-acetylneuraminic acid (Neu5Ac) is the predominant sialic acid form in ABP 710 (< 1.6%) whereas N-glycolylneuraminic acid (Neu5Gc) is the predominant form in US-licensed Remicade (3.1-10.0%). This difference is also due to the different cell lines used for production. While sialyation has a low potential to impact Fc effector functions, it has the potential to impact other antibody functional domains and could result in differences in bioactivity related to the Fab arm functionality However, comparative analyses of ABP 710 and US-licensed Remicade showed the difference of low-level sialylation had no observed effect on any receptor binding or functional assay activities, i.e., those indicative of Fab arm functionality. Therefore, the differences noted in glycosylation levels and species do not preclude a demonstration of highly similar.

The totality of the analytical similarity evidence supports the following conclusions:• ABP 710 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinical

inactive components.• For attributes where differences were observed between ABP 710 and US-licensed Remicade, the

totality of the analytical data supports that the function, activity, and in vitro stability are not impacted. Specifically, the differences noted in size variants and charge variants were not reflected in functional assays such as TNF-α neutralization assay and ADCC assay. Therefore, these differences are do not preclude a demonstration that ABP 710 is highly similar to US-licensed Remicade.

E. Same Strength:APB 710 has the same dosage form and route of administration as U.S.-licensed Remicade. Amgen is seeking approval of 100 mg ABP 710 in a vial. U.S.-licensed Remicade is available at this strength in a vial. Amgen is seeking approval for the same strength as U.S.-licensed Remicade. Comparative protein concentration upon reconstitution (mg/mL) was assessed as part of the comparative analytical assessment. The deliverable volume (mL) and fill weight data were assessed

The proposed presentation of ABP 710 has the same total content of drug substance in units of mass in a container as U.S.-licensed Remicade (100 mg). The strength of ABP 710 vial is the same as that of U.S.-licensed Remicade.

III. Summary of Quality Assessments:

A. CQA Identification, Risk and Lifecycle Knowledge Management

Table 1 below is a summary of critical quality attributes and the associated control strategies for attributes that are relevant to both Drug Substance and Drug Product. For additional information, see the primary


(b) (4)




reviews, including the Drug Substance Quality Review and Drug Product Quality Review by OBP/DBRRII and the Drug Substance Microbiology Review and the Drug Product Microbiology Review by OPF/DMA.

Table 1: Active Pharmaceutical Ingredient CQA Identification, Risk and Lifecycle Knowledge Management

CQA (type) Risk Origin Control Strategy OtherTNF-α binding and neutralization (potency)

Efficacy Intrinsic to molecule

High-molecular weight species; (product-related impurity)

Efficacy, pharmacokinetics, and immunogenicity

Manufacturing process and storage conditions. Can form due toagitation, temperature, or light exposure.

HWM fraction has similar potency to monomer.

Fragmentation (product-related impurities)


Manufacturing process and storage conditions. Fragmentation may be caused by agitation, temperature, or light

Characterization by non-reducing CE-SDS testing.

Acidic and basic variants (product-related variants and impurities)


Fermentation, purification, deamidation during storage

oxidation (CDR) (product related impurity)

Efficacy and safety

Manufacturing process and storage conditions

Deamidation (CDR) (product related impurity)

Efficacy and safety

Manufacturing process and storage conditions

Glycosylation Efficacy and pharmacokinetics

process


(b) (4)

(b) (4)

(b) (4) (b) (4)




CQA (type) Risk Origin Control Strategy Other

Protein Concentration and Protein Content

Efficacy, pharmacokinetics, safety

Manufacturing process

ADCC Efficacy Intrinsic to molecule

PMC to add a functional or FcγRIIIa binding assay to DS release specification

CDC Efficacy Intrinsic to molecule

Reverse signaling via mTNF-α

Efficacy Intrinsic to molecule

Identity (identity) Safety, efficacy Intrinsic to

molecule

B. Drug Substance [infliximab-axxq] Quality Summary

CQA Identification, Risk, and Lifecycle Knowledge Management

Table 2 below summarizes the critical quality attributes and their control strategy that are relevant specifically to the Drug Substance. For additional information, see the primary reviews, including the Drug Substance Quality Review and Drug Product Quality Review by OBP/DBRRII and the Drug Substance Microbiology Review and the Drug Product Microbiology Review by OPF/DMA.

Table 2: Drug Substance CQA Process Risk Identification and Lifecycle Knowledge Management. CQA (type) Risk Origin Control Strategy OtherAppearance (color and clarity)

Safety Manufacturing process


(b) (4)

(b) (4)




CQA (type) Risk Origin Control Strategy OtherHost Cell Proteins(process-related impurity)

Safety and immunogenicity

Derived from host cell line

Host Cell DNA(process-related impurity)

Safety Derived from host cell line

(process-related impurity)

Safety and immunogenicity

Process-related impurity


Safety


Safety


Safety


Safety


Safety


safety


Safety From raw materials

Virus Contamination (contaminant)

Safety Contamination during manufacture

Retrovirius like particles

Safety Derived from CHO cell-substrate


(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)




CQA (type) Risk Origin Control Strategy Other

(excipient)

Safety, stability Manufacturing process

Endotoxin Safety, Purity Raw materials and manufacturing process

Bioburden Safety, Purity and Efficacy due to degradation or modification of the product by microbial contamination

Raw materials and manufacturing process

• Description: ABP 710 is a recombinant human-murine chimeric monoclonal antibody of the immunoglobulin G1 (IgG1) subclass consisting of 2 heavy chains and 2 light chains of the Kappa subclass. ABP 710 contains 32 total cysteine residues involved in both intrachain and interchain disulfide bonds. Each heavy chain contains 450 amino acids with 4 intrachain disulfides and each light chain contains 214 amino acids with 2 intrachain disulfides. Each heavy chain contains an N-linked glycan at a consensus glycosylation site on asparagine 300. ABP 710 has a molecular weight of approximately 148.5 kDa. ABP 710 Drug Substance is formulated for Drug Product filling and is stored as a

• Mechanism of Action (MoA): ABP 710 binds specifically to tumor necrosis factor alpha (TNF-α) and blocks its interaction with receptors (TNFR-1 and TNFR-2). TNF-α, expressed by immune cells and other cells in response to infection or inflammation, is expressed both as a soluble cytokine (sTNFα) and a membrane-bound (mbTNFα) form. Elevated levels of TNF-α are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TNF-α plays an important role in both the pathologic inflammation and the joint destruction that are characteristic of these diseases. ABP 710 binds to mbTNFα on immune cells and induce apoptosis through “reverse signaling”. ABP 710 can induce multiple effector functions that dependent on binding to mbTNFα, including antibody-dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). These activities have been suggested to contribute to inflammatory bowel disease indications, although the significance of the contribution of any of these individual mechanisms not well established (based on literature review).

• Potency Assay: The potency assay measures inhibition of soluble TNFα-induced apoptosis in a human monocyte cell line that expresses TNF receptors (U-937 cells). The assay measures relative caspase-3 and caspase-7 levels, which are proportional to the apoptosis of cells, using a luminescence detection method. ABP 710 causes a dose-dependent loss


(b) (4)(b) (4)

(b) (4)




in luminescence signal. This activity is reported as a percentage of the activity of the reference standard.

• Reference Materials: A well characterized primary reference standard was derived from a clinical batch manufactured at Amgen Thousand Oaks (ATO) with process comparable to the commercial process. A working reference standard has been manufactured and qualification is ongoing. Amgen plans to qualify a working reference standard against this primary reference standard. A protocol is provided for the qualification of future primary and working reference standards. The protocol contains adequate testing and acceptance criteria. The implementation of a new reference standard will be reported in annual report. Both primary and working reference standards are re-tested

• Critical starting materials or intermediates:

Raw materials used in commercial manufacture are of non-animal origin.

• Manufacturing process summary:


(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)




• Container closure:

• Dating period and storage conditions: The applicant conducted real-time stability studies at °C for 4 clinical batches and 3 process validation batches. These data are also supported by accelerated and stressed stability studies. These data support a dating period of months at °C in

The stability testing program is adequate and consistent with ICH Q5C

recommendations.

C. Drug Product [Avsola] Quality Summary:

Table 3 provides a summary of the identification, risk, and lifecycle knowledge management for drug product CQAs that derive from the drug product manufacturing process and general drug product attributes.

Table 3: Drug Product CQA Identification, Risk, and Lifecycle Management

CQA (type) Risk Origin Control Strategy OtherAppearance (lyophilized cake) safety Manufacturing

process

Appearance (color) safety Manufacturing

process

Appearance (visible particulates) safety Manufacturing

process

Appearance (clarity and color) safety Manufacturing

process

Content uniformity

Control of dosing



(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4) (b) (4)

(b) (4)




CQA (type) Risk Origin Control Strategy OtherSub-visible particles (general)

SafetyManufacturing process, product degradation

Reconstitution time (general) Safety, efficacy

Manufacturing process, storage conditions

Moisture content (general) Stability

Manufacturing process, loss of container closure integrity

pH (general) Safety, efficacy FormulationOsmolality Safety, stability Formulation Filling volume (general)

Control of dosing


Sterility (contaminant)

Safety (Infection), Purity and Efficacy (degradation or modification of products by contaminating microorganisms)

Contamination may be introduced throughout the manufacturing process or through failure of the container closure integrity

Endotoxin(contaminant)

Safety, purity, and immunogenicity

Raw materials; contamination may be introduced throughout the DP manufacturing process

Container closure integrity

Safety (maintenance of sterility during shelf-life)

Container closure breaches during storage. May be impacted by storage conditions.

• Potency and Strength: Potency of ABP 710 is considered, for the purposes of this review, as the percent inhibition of TNF-α-induced apoptosis activity relative to the current reference standard. The potency assay is the same as those described in the Drug Substance section of this review.

ABP 710 is supplied as a 100 mg lyophilized solid in a single-use vial. The lyophilized powder in the vials is to be reconstituted in 10 mL sterile water for injection, yielding a 100 mg/10 mL solution. There is % overfill to assure that 10 mL reconstituted solution can be withdrawn per the produc abeling. Comparative data for protein concentration demonstrate that ABP 710 (100 mg lyophilized solid in a single-use vial) has the same


(b) (4)

(b) (4)




total usable content of therapeutic antibody and the same concentration of antibody upon reconstitution as US-licensed Remicade. The proposed ABP 710 presentation (100 mg lyophilized solid in a single-use vial) meets the statutory same strength requirement under section 351(k)(2)(A)(i)(IV) of the PHS Act.

• Summary of Product Design: ABP 710 will be supplied as a sterile, preservative-free lyophilized powder in 20 mL vials. The lyophilized powder is to be reconstituted in sterile water for injection and further diluted into 0.9% sodium chloride solution in an infusion bag.

• List of Excipients: Excipients include dibasic sodium phosphate, anhydrous, monobasic sodium phosphate, monohydrate, sucrose and polysorbate 80. Except for the antibody itself, all ingredients meet compendial requirements (USP/NF, Ph. Eur. and/or JP) and are commonly used for formulation of biopharmaceuticals. No excipients are of human or animal origin.

• Reference Materials: The same reference standard is used for Drug Product as for Drug Substance. Refer to the Drug Substance reference standard section above.

• Manufacturing process summary: The manufacturing process for Drug Product includes the following steps:

• Container closure: The primary packaging material for ABP 710 Drug Product consists of a clear and colorless 20 mL

• Dating period and storage conditions: The sponsor conducted real-time, accelerated, and thermal-stressed stability studies on 3 commercial Drug Product lots and 5 clinical Drug Product lots. These data support a dating period of 48 months when stored at 2 to 8°C.


(b) (4)

(b) (4)

(b) (4)




• List of co-package components: None.

D. Biopharmaceutics Considerations: None

E. Novel Approaches/Precedents: None

F. Any Special Product Quality Labeling Recommendations: None

G. Establishment Information:

Overall Recommendation:DRUG SUBSTANCEFunction Site

InformationDUNS/FEI Number

Preliminary Assessment

Inspectional Observations

Final Recommendation

Drug substance manufactureDrug substance in-process, lot release, and stability testingWorking cell bank storage Unprocessed bulk testing: mycoplasma

Drug product lot release and stability testing

Immunex Rhode Island Corporation(Referred to as Amgen Rhode Island or ARI)

Rhode Island, United States

968084785/3003359885

VAI 1. Inadequate procedure for investigating out of specification results.

2. Your quality unit failed to provide adequate oversight to ensure instrumentation is calibrated and maintained according to written procedures and an established schedule.

3. Your firm failed to conduct adequate deviation investigation.

4. Your quality unit fail to provide adequate oversight over critical manufacturing steps.

Approve

Drug substance in-process, lot

Amgen Inc 039976196/2026154

----- Waived Approve





release, and stability testingMaster cell bank and working cell bank storageWorking cell bank manufacture

Drug product lot release and stability

(Referred to as Amgen Thousand Oaks or ATO)

California,United States

Drug substance in-process, lot release, and stability testing

Drug product lot release and stability testing

Amgen Technology Ireland UC (Referred to as ADL)

Dun Laoghaire,Ireland

896293920/3002808497


Master cell bank storage Working cell bank storage

Amgen Inc.(Referred to as Louisville Distribution Center or LDC)

Kentucky,United States

787632801/3003750095


Mycoplasma testing (unprocessed bulk)Adventitious viral testing (unprocessed bulk)


DRUG PRODUCTFunction Site

InformationDUNS/FEI Number

Preliminary Assessment

Inspectional Observations

Final Recommendation

Drug product manufacture, drug product in-process and lot release testing


Drug product packaging and labeling

Amgen Manufacturing Ltd (referred to as AML)Puerto Rico

785800020/1000110364



(b) (4)

(b) (4)




United States

H. Facilities: A pre-license inspection for ABP 710 drug substance manufacture was conducted on April 15-19, 2019 at ARI. A 4-item FDA Form 483 was issued and the initial recommendation is approval for the BLA. The final classification of the ARI pre-license inspection was acceptable.

The pre-license inspection of the drug product site was waived because of the site’s compliance status and its recent surveillance inspection

I. Lifecycle Knowledge Management:

a. Drug Substance:

i. Protocols approved: Stability protocol for the extension of shelf life, annual stability protocol, qualification of WCB, qualification of reference standards, annual stability testing for primary and working reference standards.

ii. Outstanding review issues/residual risk: See PMC in section I. Recommendationsiii. Future inspection points to consider: None

b. Drug Product

i. Protocols approved: stability protocol for the extension of shelf life, annual stability protocol, comparability protocol for implementation of a new

comparability protocol for the addition of Amgen Technology Ireland UC, Dun Laoghaire, Ireland as a manufacturing facility for ABP 710 drug product.

ii. Outstanding review issues/residual risk: Noneiii. Future inspection points to consider: None


(b) (4)

(b) (4)

(b) (4)




Quality Assessment Summary Tables

Table 1: Noteworthy Elements of the Application

# Checklist Yes No N/AProduct Type1. Recombinant Product x2. Naturally Derived Product x3. Botanical x4. Human Cell Substrate/source material x5. Non-Human Primate Cell Substrate/Source Material x6. Non-Primate Mammalian Cell Substrate/source material x7. Non-Mammalian Cell Substrate/Source Material x8. Transgenic Animal source x9. Transgenic Plant source x10. New Molecular Entity x11. PEPFAR drug x12. PET drug x13. Sterile Drug Product x14. Other: [fill in information]Regulatory Considerations15. Citizen Petition and/or Controlled Correspondence Linked

to the Application [fill in number]x

16. Comparability Protocol(s) x17. End of Phase II/Pre-NDA Agreements tem x18. SPOTS (special products on-line tracking system) x19. USAN assigned name x20. Other [fill in] xQuality Considerations21. Drug Substance Overage x22. Formulation x23. Process x24. Analytical Methods x25.

Design SpaceOther x

26. Other QbD Elements x27. Real Time release testing (RTRT) x28. Parametric release in lieu of Sterility testing x29. Alternative Microbiological test methods x30. Process Analytical Technology in Commercial Production x31. Drug Product x32. Excipients x33.

Non-compendial analytical procedures Drug Substance x

34. Human or Animal Origin x35. Excipients Novel x36. Nanomaterials x37. Genotoxic Impurities or Structural Alerts x38. Continuous Manufacturing x39. Use of Models for Release x40. Other {fill-in} x


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