COMMERCIALIZATION STRATEGIES IN GLOBAL BIOSIMILARS INDUSTRY
A Frost & Sullivan Executive Think Tank and Dinner Market Survey

Thursday, September 6, 2018 | 6:00 PM - 9:00 PM

The responses to the survey questions will be used as the foundation of the dinner conversation.

Question Title

* 1. Please enter in your information below. Thank you!

Name:

Company:

Title:

Email Address:

Phone Number:

Question Title

* 2. What are key growth drivers & restraints- both for types of biosimilars (MABs, Insulin etc)?

Emergence of a supportive regulatory approval pathway

Patent expires on major biological products

Government cost savings initiatives (promote high quality, low cost drugs)-example UK NHS adopted biosimilar forms of rituximab from Celltrion and Novartis -discounts of 50 to 60 percent

Physician’s lack of trust leading to slow adoption in U.S

Transparency on total costs

Strong trust with innovator brand

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* 3. Which regions and countries present the greatest potential for the biosimilars business? Why?

Americas (US, Canada, Brazil)

Western Europe (Big 5 versus Scandinavian countries)

Eastern Europe, CIS/CEE

Asia (India, China, Japan, S. Korea, Australia)

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* 4. What would be short term, midterm, and long term impact of current and future regulatory landscape governing biosimilars?

Market exclusivity issues- Biosimilar penetration relative to initial sales of biologic reference product

Centralized procurement issues-Country wise regulatory frameworks supporting role of buyer institutions/tenders

Pricing issues-(Example in US) Policies that lowers prices instead of adding another product to the market based on interchangeability guidelines

Competition issues- Purchasing policies at the country (US) or region (EU), state and private level that drives extreme price competition between biosimilars and innovator drugs

Collaboration between innovators and Biosimilar manufacturers

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* 5. How have manufacturers responded to changes in Interchangeability guidelines?

Design issues- Increased provision on structural data & switching studies to support a demonstration of interchangeability

Process & clinical development issues- Increased evidentiary FDA/EMA standards driving cost and time prior to approval including post-approval studies

Manufacturing issues- Focus to control differences in long term outcomes between reference product and an interchangeable one (i.e. efficacy, immunogenicity)

Reimbursement issues- 2018 CMS guidelines that assigns separate healthcare product codes for biosimilars covered under Medicare Part B

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* 6. What tactics will be most critical success of bio similar companies?

Increasing capacity

Increasing Internal R&D investments

Strategic alliances with Big Pharma/Originators, CDMOs

M&A

Geographical market selection

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* 7. What are unique Capabilities & Strategies of Innovators (ex; Amgen) vs Pure Biosimilar (Samsung Bioepis) Companies?

Establishing large capacity (>100,000L) Manufacturing platform, Fed batch stain less steel, single use connected continuous with fed batch or perfusions system

Access to specialized resources (Cell Banking, Clean room technology, N-1 perfusion services)

Strong Financial capability

Differentiated value proposition: CDMO model (process development & manufacturing services) based on limited exclusive partnerships

Large R&D pipeline

Diversified portfolio (Immunotherapy, oncology, Neurology, Lifestyle Diseases

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* 8. What are the key drivers of affecting cost targets of biosimilars’ deployment and their effect on cost of process development and of manufacturing?

Solid understanding of the reference product

Establishment of comparison metrics with reference product (difference in molecular structure 3D structure & glycosylation, composition and bioactivity, isoforms and impurities excipients and formulations)

Establishment of the quality target product profile (QTPP) early in the development cycle; managing analytical testing (physiochemical and biological assays) costs

Determining appropriate number of lots to evaluate are representative of the potential variability, during storage conditions

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* 9. What is the impact of process development and manufacturing innovation in UPSTREAM MANUFACTURING on the success of Biosimilars?

Economics on Mammalian vs. Bacterial lines

Establishing comparability and match CQA to reference products

Development of Bio-betters

Reference product CQA characterization (improved safety, efficacy)

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* 10. What is the impact of process development and manufacturing innovation in DOWNSTREAM MANUFACTURING on the success of Biosimilars?

Economics on Protein A versus other systems

Improved glycosylation rates etc.

Improved QA/QC process analytics value chain

Develop unique cell lines and manufacturing process

Establishing comparability and match CQA to reference products

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* 11. What are Clinical Development & IP strategies employed by manufacturers that define commercialization pathways for Biosimilars & Biobetters?

Thank you for your feedback! Upon submitting this survey you will receive a calendar invite to hold the date. Looking forward to seeing you on Sept. 6!