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Speakers:
Sheldon Bradshaw, Partner, Hunton & Williams LLP
Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Andrew N. Papas, Vice President, Regulatory Affairs, NSF Health Sciences Pharma Biotech Consulting
Jur Strobos, Of Counsel, Olsson Frank Weeda Terman Matz PC
Moderated by Susan Lee, Senior Associate, Hogan Lovells US LLP
1
Promotion of Biosimilars
Promotion of Biosimilarsand the First Amendment
Sheldon T. Bradshaw
Hunton & Williams LLP
October 2, 2015 [email protected]
202-955-1575
2
Biosimilars: Advertising and Promotion
The First Amendment
• What impact, if any, will the First Amendment have on FDA’s application of traditional standards governing advertising and promotional materials to Biosimilars?
• The tension between FDA’s policies and First Amendment protections has come to a head a number of times over the last two decades.
• The manner in which FDA regulates the dissemination of truthful and non-misleading information is once again squarely under the First Amendment spotlight.
October 2, [email protected]
202-955-1575
3
WLF Litigation
• In a series of cases from 1998-1999, the Washington Legal Foundation (“WLF”) challenged FDA’s policies and regulations that restricted the dissemination of truthful, non-misleading information.
• The federal district court for the District of Columbia recognized that the First Amendment may, and in certain specific instances does, protect a manufacturer’s right to disseminate (and a physician’s right to receive) truthful, non-misleading information regarding uses of an FDA-approved drug outside of FDA’s approved labeling.
October 2, [email protected]
202-955-1575
4
Western States• The Supreme Court recognized that pharmacies have
the right to promote drug compounding services under the First Amendment.
• FDA sought public comment regarding the impact of the First Amendment on its regulations.
• FDA expressly acknowledged that there may be tension between certain aspects of the Agency’s authority and judicial developments, and requested comments on (among other issues) a manufacturer’s ability to communicate information regarding off-label promotion.
October 2, 2015
202-955-1575
5
Sorrell v. IMS Health, Inc.• In 2011, the U.S. Supreme Court held that “[s]peech in
aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”
• Impact of Sorrell predicted by the dissenting Justices. Justice Breyer writing for himself and two others warned that “the same First Amendment standards that apply to Vermont here would apply to similar regulatory actions taken by other States or by the Federal Government acting, for example, through Food and Drug Administration (FDA) regulation.”
October 2, 2015
202-955-1575
6
United States v. Caronia
• In 2012, the Second Circuit applied Sorrell to vacate the criminal conviction of a sales representative who had been prosecuted for “misbranding” based on truthful and non-misleading off-label marketing claims.
• Court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FD&C Act for speech promoting the lawful, off-label use of an FDA‑approved drug” consistent with the First Amendment.
October 2, [email protected]
202-955-1575
7
Amarin Pharma, Inc. v. FDA• In May 2015, the threat of FDA prosecution led Amarin
Pharma, Inc. and four physicians to file a lawsuit against FDA to prevent FDA from prosecuting the company for truthful, non-misleading statements regarding off-label promotion of its FDA-approved drug product.
• On August 7, 2015, the United States District Court for the Southern District of New York granted Amarin’s motion for a preliminary injunction, concluding that Amarin had demonstrated a likelihood of success on its claim that the First Amendment protects truthful, non-misleading manufacturer communications regarding off-label use.
October 2, 2015 [email protected]
202-955-1575 8
Biosimilars – Implications for Labeling, Advertising and Promotion of Biologics
FDLI Advertising and Promotion ConferenceBruce A. Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals Inc.October 2, 2015
Momenta Pharmaceuticals, Inc.
Momenta Employees
10
Corporate Info• Founded in 2001; IPO 2004• Located in Cambridge, MA• ~250 employees; >75% in R&D
An Advanced Analytic Platform• Expertise in high-resolution analytics,
biological characterization, and process engineering
Driving Potential in Three Areas• Complex Generics• Biosimilars• Novel Drugs
With a Track Record of Success• Breakthrough success with
• 2010 generic Lovenox approval • 2015 generic Copaxone approval
11
PROGRAMS PRECLINICAL/PROCESS DEVELOPMENT CLINICAL1 ANDA/BLA/NDA
FILED MARKETED
ComplexGenerics1
Enoxaparin Sodium Injection (Generic Lovenox®)*
GlatopaTM (Generic 20 mg/mL Copaxone®)*
M356 (Generic 40 mg/mL Copaxone®)*
Biosimilars
M923 Adalimumab (HUMIRA®)**
M834 Abatacept (ORENCIA®)
M511 Bevacizumab (AVASTIN®)
6 Early Stage Biosimilar Programs
Novel Drugs
Necuparanib - pancreatic cancer
hsIVIg (Hyper-sialylated IVIg)
SIF3 (Selective Immuno- modulator of Fc Receptors)
Anti-FcRn Antibody
Approved
ANDA Accepted
CTA Accepted/PK Study
Phase 2
1Clinical safety/efficacy trials have not been required for these complex generic drug applications
Momenta Product Portfolio: Broad Application of Thorough Characterization Across Complex Generics, Biosimilars, and Novel Drugs
*In collaboration with Sandoz
**In collaboration with Baxter
Scientific Principles Applied to the Review of Generic Lovenox are Applicable to the Review of Biosimilar Candidates
14
“…Such a “totality of the evidence” approach can also be applied to assessing biosimilars, since it seems possible to exceed a current state-of-the-art analytic
characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary methods. There may be
strategies that allow a “fingerprint”-like identification of very similar patterns in two different products. Such strategies were used in supporting the
approval of a generic low-molecular-weight heparin product, enoxaparin — which, though it differs from proteins in important ways, is structurally complex.
Although additional animal and clinical studies will generally be needed for protein biosimilars for the foreseeable future, the scope and extent of such
studies may be reduced further if more extensive fingerprint-like characterization is used.”
Property of Momenta Pharmaceuticals and should not be reproduced or distributed
to any third party without Momenta’s prior approval.
Innovation to Thoroughly Define Biologics
Understanding the nonlinear chemical
and biosynthetic reactions that drive
production
Control of Manufacturing
*
*
High resolution physicochemical analytics
platform to thoroughly characterize any
product
Thorough Structural Characterization Thorough Biological Characterization
High resolution biology applied pre-clinically
and in clinical settings
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Momenta’s Goal: Interchangeable Biologics
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Brand Biosimilar
Unknown
Same
Different
Unknown
Prod
uct K
now
ledg
e
Standard Approach
Same Same Same
Brand Biosimilar Brand Interchangeable
Different
Remove uncertainty. Qualify differences. Demonstrate equivalence.
• Increased POS for approval
• Reduced clinical requirements
• Opportunity for interchangeability
• Improved commercial differentiation
• Thorough Product Characterization
• Manufacturing Process Design
• Product Control and Quality
Unknown
Momenta Approach
Property of Momenta Pharmaceuticals and should not be reproduced or distributed
to any third party without Momenta’s prior approval.
• Brand Drift
• Manufacturing Change
Momenta is Committed to Enhancing Quality of Biologics and Protecting Patient Safety
17
From contamination to characterization within a matter of weeks,MNTA helped answer the complex question of the contaminant,
and published manuscripts that helped influence the screening system for others to follow.
A History of Commercial Messaging to Deter Biosimilar Innovation and Competition
Tactic Message Barriers to Competition
BIO CP - 2003 • Generic biologics are impossible
• Prevent regulatory approval• Prevent/deter legislative pathway
Oppose Biosimilar Pathway – 2007-2010
• Biosimilars are unsafe even if possible
• Interchangeable biologics are impossible/different
• Prevent/deter pathway• Incorporate legislative features that prevent/deter
use of the pathway• Mandatory clinical trials• Complex IP exchange
Influence FDA Guidance - 2011
• Same messages • Emphasize differences (e.g., naming)• Mandate unnecessary clinical trials• Freeze scientific standards for similarity and
interchangeability
AbbVie CP I • Same messages • Delay biosimilars for 10 years
Naming CampaignJnJ Citizen Petition
• Biosimilars are different and raise safety concerns
• Amplifies anti-biosimilar commercial campaign with providers, payers, patients and regulators
Restricted Access to Reference Products
• Biosimilar companies are irresponsible
• Prevents/delays initiation of development
AbbVie CP II • Biosimilars should be named and labeled differently
• Interchangeable Biologics will “appear” different and non-substitutable
18
Labeling Background
• Basic Principles and Questions• Labeling must contain adequate directions for use• Labeling must specify approved conditions or indications for
use• Labeling may not be false or misleading• Comparative and superiority claims in labeling and
promotional materials must be supported by substantial evidence and adequate and well controlled clinical trials
But: Labeling forms the predicate for biosimilar and interchangeable biologic promotion as well.
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Differential labeling is Not Mandatory
• The BPCIA is silent on labeling. The law itself does not require or preclude inclusion of biosimilarity or interchangeability data in a label• Interchangeable Biologics should include interchangeable designation
• Misleading to omit a positive designation at the Pharmacy and to Provivders• Potentially misleading to require negative statement of non-interchangeability
• Non-interchangeable biosimilars require a prescription and are not substitutable
• The CP asserts “patient safety” risk? • Assumes pharmacists will violate the law (substitution)• Assumes physicians are inexperienced• Familiar messaging to undermine confidence in biosimilars• Goal is to disparage and deter physician adoption in a protected First Amendment CP setting• Inconsistent with the BPCIA Goal of higher quality, more affordable, and more accessible biologics
• Adoption drives investment, innovation and quality
• Biosimilar Applicant may or may not seek to include additional data or interchangeability status• As with any label, should be evidence based• Additional data may be useful to demonstrate quality
• Can anti-biosimilar messaging survive biosimilar and interchangeable biologic approvals?
20
Traditional “Brand” Messaging on Biosimilars
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“Safety is a priority for the development of all medicines, but biologics raise safety
considerations above and beyond those of chemical drugs. This is because biologics are more
structurally complex medicines than chemical drugs, and even slight changes in their manufacture can
cause undetected changes in the biological composition of the product. These changes can in turn
affect the safety and effectiveness of the product in patients. The EPREX example provides a further
rationale for not considering a follow-on product to be interchangeable with an innovative
product.”
“Unlike generic medicines where the active
ingredients are identical, biosimilars are not likely to be identical to the originator biologic.
Biosimilar development requires significant expertise, infrastructure and investment to
demonstrate safety and equivalent efficacy and to ensure safe, reliable supply of therapies for
patients.”
In order to maximize benefits of the pathway, as policies and laws are developed and implemented, should we be emphasizing similarities or
differences?
Unsupported Comparative Claims are False and Misleading
22
Mandatory Unique Naming Appears to be Inconsistent with FDA Policy on Comparative Claims
• A unique biosimilar name could make a label misleading or confusing in several ways:• Does a unique name suggest a “clinically meaningful difference” when there is none?
• Does the answer differ for non-interchangeable biosimilars v interchangeable biologics?
• If a non-meaningful structural or functional difference in a biosimilar requires a naming difference, will biologic manufacturing changes (brand or biosimilar) require similar labelling changes?
• Is it false and misleading to suggest that a biosimilar poses safety concerns when a manufacturing change with similar differences may not have been tested to the same standard as the biosimilar?
• Is it false and misleading or confusing to patients to argue that biosimilars are more different than the brand than the brand is to itself? • The only well controlled studies and evidence and FDA Approval will demonstrate
otherwise
23
Can Current Messaging Survive a Biosimilar or Interchangeable Biologic Approval?
• Will existing commercial messaging survive approval of a biosimilar?
• Are they false and misleading?
24
Questions
25
A Citizen’s Petition on Biosimilar Labeling
Introduced by
Andy Papas, PhD, MBA
Vice President of Regulatory Affairs
NSF Health Sciences Pharma Biotech Consulting
Biosimilars: Advertising and Promotion
Disclosure Statement
• For the purpose of facilitating discussions on prospective labeling by experts from varying viewpoints on this topic, NSF Pharma Biotech Consulting introduces a recent recommendation for biosimilar labeling via Company X’s citizen petition
• It should not be construed that NSF is representing Company X as a client or adopts any or all of its proposed recommendations regarding US biosimilar labeling
Background
• FDA approved Sandoz's 351(k) application to market Zarxio® on 6-Mar-15 ('filgrastim-sndz'), first biosimilar drug approved in US
• Zarxio’s labeling: direct copy of reference biologic label (Neupogen) with extrapolation of 4 indications
• Company X files Citizen Petition (CP)1 and a later supplement2 for recommended biosimilar labeling
• To date, FDA has not issued draft guidance on labeling of biosimilars but issued final guidance in Apr 2015 on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry
1: Docket No. FDA-2015-P-2000, 2-Jun-2015, Citizen’s Petition, 2-Jun-2015
2: Docket No. FDA-2015-P-2000-0007, 10-Aug-2015, Supplement to Citizen Petition, 10-Aug-2015
CP Requested Biosimilar Labeling
For product licensed under section 351(k) of the PHS Act, the approved Rx drug labeling should contain:• Clear statement that product is:
– A biosimilar3 – licensed for fewer than all of reference product’s conditions of use (if
applicable)– licensed conditions of use were based on extrapolation (if applicable)
• Clear statement that FDA has not determined the biosimilar is interchangeable with reference product (if applicable)
• Concise description of pertinent data developed to support licensure, along with information to enable prescribers to distinguish data from studies of biosimilar vs. studies of the reference product
3: As observed in EU, NZ, and CA
Key CP Points4
1. Sameness of Label, Requirement of Generic Drugs, Contrary to BPCIA
2. Sameness [i.e., inflexible] Label Requirement - Misleading and Violates FDCA and FDA Regulations
3. FDA Violated the APA5 When It Abandoned the Draft Scientific Guidance Labeling Recommendations
4: FYI: No points are raised regarding pharmacoviligance reporting issues
5: Federal Administrative Procedures Act, 1946
Point 1
Sameness of Label, Requirement of Generic Drugs, Contrary to BPCIA (Biologics Price Competition and Innovation Act of 2009)• Approved label exactly that of the reference drug Neupogen• Includes all five of the Neupogen indications, four by extrapolation (sixth
approved after Zarxio approval)
Point 1 (cont.)
• “Same label” applied to Zarxio implies new FDA requirement • Why BPCIA doesn’t support label sameness approach
– Biologics different from small molecule drugs; similar but not identical– BPCIA created 2 tiered structure of biosimilarity: general biosimilar and
interchangeable– BPCIA borrowed some ANDA provisions but didn’t borrow same label
requirement– PREA amended to state non-interchangeable biosimilar is “a new active
ingredient” for purposes of pediatric research, but interchangeable product is not
– In sum, characterizing feature of BPCIA deems biosimilars to be different from their referents
• Therefore same labeling approach “legally” unsound
Point 2
FDCA misbranding violation occurs if label is false or misleading; it omits material facts• Material facts
– whether an omission is material “is determined by the degree to which [the] information is objectively important, relevant, or substantial to the target audience.”
– In other words, a material fact is one that reasonably would influence “the intended audience.”
Point 2 (cont.)
• Biosimilar labeling must include information necessary to enable informed prescribing and to dispel common misconceptions– Survey of 400 US board certified physicians thought important that label
include all the elements being petitioned in this CP
Point 2 (cont.)
• Prescribers need to know whether a product is biosimilar and nature and scope of its approval– Zarxio was approved for 5 indications, 4 by extrapolation. Reference
product approved for 6th indication after Zarxio approval. None of these facts can be derived from Zarxio’s label, resulting in materially misleading biosimilar labeling
– In preamble accompanying the physician labeling draft rule, FDA stated that “the basis for approval of the drug product, including the extent of the product’s benefits,” should be included in labeling “to provide practitioners with more accurate and specific information about a drug’s efficacy that could help them to make informed prescribing decisions.” Thus, FDA regulations provide for the basis for a drug’s approval to be disclosed in its approved physician labeling
Point 2 (cont.)
• Prescribers need to know whether biosimilar is interchangeable with reference product– Prescribers may/not be able to tell whether biosimilar meets criteria of
being interchangeable – Omitting that information is misleading and suggests that biosimilar could
be substituted for its referent which increases risk of inappropriate product switching
• Prescribers need biosimilar-specific data and also need to know whether data discussed in labeling are from biosimilar or from reference product– Immunogenicity – Zarxio’s label contained immunogenicity profile of
Neupogen® of 3% yet its profile was 0%. In addition, label also warned that 3% result should not be compared to results reported by “other filgrastim products”
– Prescriber likely to be confused and assume that 3% rate was that observed for Zarxio; therefore source of data in label should be identified
Point 3
FDA Violated the APA When It Abandoned the Draft Scientific Guidance Labeling Recommendations• FDA published draft guidance on Scientific Considerations in
Demonstrating Biosimilarity to a Reference Product; Guidance for Industry in Feb 2012
• In final guidance of Apr 2015, FDA removed the earlier labeling recommendation: – “Labeling of a proposed product should include all the information
necessary for a health professional to make prescribing decisions, including a clear statement advising that:
• This product is approved as biosimilar to a reference product for stated indication(s) and route of administration(s).
• This product (has or has not) been determined to be interchangeable with
the reference product”
Point 3 (Cont.)
• Many discussions were held with public after issuance of draft guidance and in the Agency’s view the draft guidance was “well received”
• Yet in Apr. 2015, FDA published final guidance with this entire section removed
• APA requires “unwavering” obligation on agencies to provide a reasoned explanation for their policies
• FDA cannot abandon that proposal without comment, leaving regulated entities and other key stakeholders to guess its “unspoken thoughts”
Supplement to Citizen Petition
1. FDA Purple Book5
– On 30-Apr-2015, Senate HELP Committee chairman plus others requested FDA via letter to explain why first approved biosimilar label contained no statement regarding the product’s interchangeability status
• Under what circumstances should label disclose it had not been found interchangeable?
– On 22-Jun-2015, FDA responded that omitted interchangeability would not be needed on biosimilar label because information could be found in Purple Book
– Assertion - FDA defends material omission in Zarxio’s Package Insert on grounds that relevant information can be obtained from another, non-labeling source
• Ironic twist - without “biosimilar” in label, prescriber would not know to consult biosimilar Purple Book
5: FDA’s Purple Book: “Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations”
Supplement (cont.)
– FDA regulations6 explicitly state that prescription drug labeling found "on or within the package" (in other words, the package insert) must contain all of the information that prescribers require to administer the drug to their patients safely and effectively.
2. Amarin Pharma Inc. v. FDA – FDA letter sent to DOJ on 8-Jun 2015, includes FDA statement on permissible
marketing of Vascepa®:– Communication should not state or imply that studies conducted using products
other that Vascepa were studied of Vascepa itself… – Similarly in brief filed with court on 23-Jun-2015, DOJ (on behalf of FDA)
asserted that it would be “misleading for Amarin to suggest or imply …that studies using products other than Vascepa were studies of Vascepa itself”
3. Information provided demonstrating additional stakeholder support for the CP’s recommended labeling
6: 21 CFR 201.100(c)(1)
FDLI Key Discussion Points• What information is needed by prescribers/pharmacists regarding
biosimilar labeling – Should biosimilar or interchangeability declaration be required in prescribers
label?– Should the clinical data supporting licensure of biosimilar be required in label?
• What information is needed by patients?• Can/should the Purple Book serve as surrogate communication
vehicle?
Contact Information:
Andy Papas
Application of Traditional Standards to Biosimilar
Labeling
Jur Strobos MD
Attorney at Law
Olsson Frank Weeda Terman Matz PC
October 2, 2015 [email protected]
240-472-9665
42
Biosimilars: Advertising and Promotion
Overview• Proposed Alternative Views of Labeling
– Copy Reference Label – ‘Genericized’– Include Provisos
• Evidentiary standards for claims– Comparison Claims
• How is a biosimilar actually different?– Examples from filgrastim sndz– Statutorily permissible differences
• What is truth?
October 2, [email protected]
240-472-9665
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Labeling• Efficacy (indication/usage/clinical studies)• How and Why (dosing, administration, how
supplied, clinical pharmacology)• Safety (contraindications, warnings,
precautions, adverse reactions, interactions, special populations, nonclinical pharm/tox, overdose)
• Proprietary information (mfg, name, etc.)
October 2, 2015
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Generic Drugs• All components of labeling other than
proprietary information are copied– But, none of the copied information was
generated by the generic sponsor• Unique clinical or other information
generated by sponsor NOT on the label– Mfg, bio-availability,1 -equivalence,1
extrapolation of use• Is this truthful? Or, dictated by 505(j)2, 3?
October 2, [email protected]
240-472-9665
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1§505(j)(2)(A)(iv) (“bioequivalence”);
2§505(j)(2)(A)(iv) (“same therapeutic effect”);
3§505(j)(2(A)(v) (“same”
“labeling”)
Recent Citizen’s Petition:1
Add Four Provisos to Label
• Product is “biosimilar” (or “interchangeable”)• Product is NOT biosimilar for certain
specified uses• Labeled Indication/Usage based on
extrapolation• Include summary of data actually generated
by the sponsor of the biosimilar
October 2, 2015 [email protected]
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1Docket No. FDA-2015-P-2000
How Is BPCIA Different?• “Biosimilar”1 or “highly similar”2
– No “clinically meaningful” differences3
– Any differences are “clinically inactive”2
• Has to specify “mechanisms of action for the condition or conditions of use” “to the extent known for the reference product.”4
• “Same” labeling re how to use.• But, elsewhere, does not specify “same”
labeling
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1PHS §351(k)(2)(A)(i)(I);
2PHS §351(k)(2)(A)(i)(I)(aa); PHS
§351(i)(2)(A);
3PHS
§351(i)(2)(B);
4PHS §351(k)(2)(A)
(II)
Statutory Evidentiary Standards
• Efficacy data:– “[S]ubstantial evidence” based on “adequate
and well-controlled investigations, including clinical investigations”1
• Other data:– “Adequate tests” to support “conditions” “in
the labeling”2
• “Reasonable evidence”3
• “Some basis to believe”4
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1FDCA § 505(d)(5), (7)
2FDCA § 505(d)(1)
321 CFR § 201.57(c)(6)
421 CFR § 201.57(c)(7)
Comparative Claims• Comparisons of efficacy must be
supported by substantial evidence1
• Comparisons of safety must also be supported by substantial evidence– E.g., “frequency, severity or character of
adverse reactions”2
October 2, [email protected]
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121 CFR § 201.57(c)(3)(v)
221 CFR § 201.57(c)(7)(iii)
Data to Establish Biosimilarity1
• Analytical studies (physico-chemical)• Nonclinical• Clinical
– PK/PD, immunogenicity, maybe other• Sufficient to support 1 or more conditions for use
• Same mechanism of action if known• BPCIA does not require substantial evidence
of comparative efficacy or safety for approval
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1PHS §351(k)(2)(A)(i)
Filgrastim sndzComparability Data
• Analytical (CMC)• Immunogenicity• Pharmacology/Toxicology• Clinical Pharmacology• Clinical/Statistics
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Analytical
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1FDA Briefing Document at page 17-12; Addendum at 1-7
• Are these differences clinically active?
• Statistically meaningless1
Immunogenicity/PK/PD
• Comparison of Anti-Drug Antibodies– Differences within limits of assay accuracy
• Comparison of Neutralizing Antibodies– No positives for either
• PK variability less than required for generics
• No identified PD differences within historically published variability
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Clinical Safety and Efficacy
• Open label (EP06-301)– Does not meet criteria of substantial evidence
• Comparative (EP06-302)– 1:1 N≈200– Met retrospective noninferiority margin– Does not meet criteria for substantial evidence
• Given size/design, were these studies probative? Necessary?
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Conclusion• Comparative claims to other marketed
products – whether relative safety or efficacy – are inherently efficacy claims1
– Must be supported by “substantial evidence”– BPCIA does not require substantial evidence to
support a finding of biosimilarity (or interchangeability)
• The words “similar” or “not similar” are comparative claims
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121 CFR § 201.57(c)(3)(v); 21 CFR § 201.57(c)(7)(iii)
Conclusion II• BPCIA requires extrapolation of indications
for a biosimilar based on mechanism of action, and other limited data
• These data do not include substantial evidence
• Statements related to support or lack of support for specific indications could be construed as a comparative claim
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If BPCIA precludes the agency from requiring substantial evidence to support a finding of biosimilarity, can FDA require
labeling that contains unsubstantiated comparative claims?
Or permit comparative promotional claims?
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Questions?
58
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