Original Biologics Pave Way for Follow-on-VersionsOriginal Biologics Pave Way for Follow-on-Versions

An OverviewAn Overview

Sandhya Kamath, Industry ManagerHealthcare

18 June 2013

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Today’s Presenter

Expertise:

Nine years of life-sciences expertise, which include laboratory and technology research; and consulting which comprises: •Strategic planning, building roadmaps and predictions in the research services, and mentoring a team of analysts present globally •Experience working on projects for industry sector analysis and forecast (genetics, drug discovery and clinical diagnostics), and presenting findings on industry trends and growth opportunities to audiences and clients•Leading customized projects for companies and research institutions in technology areas like stem cells, SNPs, bone-healing, enzymes, bio-informatics to name a few

Years of experience:

Possesses 6 years of research and consulting experience with Frost and Sullivan in monitoring and analyzing technologies in the healthcare domain. Brief work-experience in Dubai, UAE. Prior to this organization, worked in the drug-informatics domain of Jubilant. group

Sandhya Kamath,

Industry Manager, HealthcareTechnical Insights Unit, Frost & Sullivan

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Biosimilars

What’s making news?

1.Generics players and atypical brands enter the biosimilars industry2.Partnerships and alliances continuously established for R&D (or) marketing

Why the hoopla?

1.Between now and 2020, patents expire for >20 biologics2.Enactment of legislation for approval in major regions

How does it benefit the payer / patient?

1.Access to block-buster drugs at a lower cost especially in developing countries. 2.Since manufacturing costs and time to market are less than innovator product, this will translate into reduced medical expenditure

‘Similar to’ a biological drug

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Agenda

Market overview

Challenges

Technology platforms

Regulatory framework

Applications

Conclusion

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Market Overview

Revenue forecast for the total biosimilars market globally

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Market Overview

Competitive environment in biosimilars. Companies with a strong integration of marketing and R&D are likely to succeed

Pha

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Gen

eric companies

Contract research

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Challenges

BiosimilarsBiosimilars

Evolving regulatory environmentEvolving regulatory environment

Interchangeability and biosimilar substitutionInterchangeability and biosimilar substitution

Slow rate of uptakeSlow rate of uptake Affordability in emerging economiesAffordability in emerging economies

Brand loyaltyBrand loyalty

Complex manufacturing process and high investmentComplex manufacturing process and high investment

The current and future scenario

Current… Future…

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Technology Platforms

Company Region Technology

Selexis NA SUREtechnology Platform, which uses SURE CHO-M Cell line

Neuclone Pty Limited Australia

NeuCHO derived from the DHFR-deficient DG44 cell line, in serum-free and animal protein free mediapNeu and pNeuMAB DNA vectors for high-level expression of single-chain and multi-chain proteins in NeuClone’s cell lines;NeuGRO medium to support all stages of cell line development

Catalent NA GPEx technology - is a pseudo-typed, high-titer vector that generates stable mammalian cell lines

Lonza EU GS Gene Expression System

PanGen Biotech KoreaPanGen has developed novel mammalian cell expression systems that can efficiently produce proteins from CHO cells

Expression systems

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Technology Platforms

Company Region Technology

3M purification technologies NA Zeta Plus™ depth filtration technology

Xcellerex Inc.. Unit of GE Healthcare Life Sciences

NA

FlexFactory® Biomanufacturing PlatformXDR™ Single-Use BioreactorsXDM QUAD Single-Use Mixing Systems

Intrexon Corporation NA UltraVector® platform (Full platform for engineering, identification and purification)

Cellexus Limited EU CellMaker PLUS

Asahi kasei JapanPlanova BioEX filtersBioOptimal MF-SL

Manufacturing technologies

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Regulatory Framework

Not well defined pathway

Regulated markets

Semi-regulated markets

Regional overview of biosimilar pathways. Approved biosimilars in key markets

India6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin

India6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin

USA / Canada1 Class: HGH

USA / Canada1 Class: HGH

Japan3 classes: EPO HGH G-CSF

Japan3 classes: EPO HGH G-CSF

Europe3 classes: EPO HGH G-CSF

Europe3 classes: EPO HGH G-CSF

China6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin

China6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin

CEE5 classes: EPO HGH G-CSF Interferon Insulin

CEE5 classes: EPO HGH G-CSF Interferon Insulin

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Applications

Currently biosimilar EPO, GCSF, and Growth hormones have been approved and launched in different countries

Insulin's and Monoclonal antibodies are under development and stages of approval

Cancer and Diabetes, are the therapeutic areas at the forefront

This slide highlights the different types of deals in biosimilars until 2012

Year Products – patent expiry

2013 Epogen, Avonex, Byetta, Humalog, Neupogen, Rebif

2014 Remicade, Novolog

2015 Herceptin, Lantus, Neulasta, PegIntron, Rituxan, Synagis

2016 Aranesp, Humira

2017 Avastin, Pegasys

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Applications

Product Class Biosimilar Product Company Therapeutic Area Active Substance

Human Growth Hormone

(HGH / Somatropin)

Omnitrope Sandoz GmbHDwarfismPituitary Prader-Willi SyndromeTurner Syndrome Somatropin

Valtropin BioPartners GmbHDwarfismPituitaryTurner Syndrome

Erythropoietin (EPO / Epoetin)

AbseamedMedice Arzneimittel Pütter GmbH & Co. KG

AnemiaCancerChronic Kidney Failure

Epoetin alfaBinocrit Sandoz GmbH

Epoetin Alfa Hexal Hexal AG

Retacrit Hospira UK LimitedAnemiaBlood TransfusionAutologous CancerChronic Kidney Failure

Epoetin zetaSilapo Stada Arzneimittel AG

Granulocyte Colony Stimulating Factor (G-CSF/ Filgrastim)

Biograstim CT Arzneimittel GmbH

CancerHematopoietic Stem Cell TransplantationNeutropenia

Filgrastim

Ratiograstim Ratiopharm GmbH

Tevagrastim Teva Generics GmbH

Filgrastim ratiopharm

Ratiopharm GmbH

Filgrastim Hexal Hexal AG

Zarzio Sandoz GmbH

NivestimHospira UK Ltd.

European biosimilars approved and marketed

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1. New seedbanks technologies are available in the field of biotechnology, especially focused on genetic engineering and monoclonal antibody technology

2. An increasing number of companies are currently offering custom antibody services for biosimilars development

1. Flexible manufacturing/ single use systems can be fine tuned for production of biosimilars

2. Smaller bioreactors will produce similar quantities to today’s “six pack” facilities

3. Consider CMOs to outsource entire manufacturing process. Alternatively, technology licensing from companies for in-house manufacturing setup

1. Inhouse development of cell lines can be opted for since these are key to development of biosimilars

2. Technologies offering higher yield (>20g/L) and speed are available for evaluation. To reduce long-term manufacturing costs, these options can be explored

3. Choosing the right kind of license with existing biotech companies

Conclusion

Seed banksCell line development

Manufacturing

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For Additional Information

Britni MyersCorporate CommunicationsHealthcare(210) 477-8481Britni.myers@frost.com

Sandhya KamathIndustry ManagerHealthcare(91) 80-67028001sandhya.kamath@frost.com

Nicolas VotanoSales DirectorTechnical Insights(212)-402-1813  Nicolas.votano@frost.com