This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be “highly similar” or “interchangeable” with a reference biological product (e.g., vaccines, antibodies, blood and blood components, gene therapies, tissues, and proteins) that have already been approved or “licensed.”
This webinar will provide an introduction to FDA’s proposed regulation of biosimilars based on past Agency statements and information contained in its recently published draft Guidance Documents. It is intended to provide an easy-to-understand primer on FDA’s suggested approach for demonstrating biosimilarity between a Reference Biological Product and a proposed copy.
Why Should You Attend:
On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDA’s proposed abbreviated approval pathway.The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be “highly similar” or “interchangeable” with a reference biological product (e.g., vaccines, antibodies, blood and blood components, gene therapies, tissues, and proteins) that have already been approved or “licensed.”
This webinar will provide an introduction to FDA’s proposed regulation of biosimilars based on past Agency statements and information contained in its recently published draft Guidance Documents. It is intended to provide an easy-to-understand primer on FDA’s suggested approach for demonstrating biosimilarity between a Reference Biological Product and a proposed copy.
Learning Objectives:
- Gain a basic understanding of FDA's proposed regulatory approach for allowing the marketing and sale of biosimilars.
- Provide attendees with an overview of the three guidance documents published by FDA earlier this year and highlight important elements of each.
- Describe the process for demonstrating biosimilarity to an identified Reference Biological Product including FDA's proposed “stepwise approach”.
- Discuss the criteria used for showing biosimilarity including a discussion of the analytical factors a company must consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product.
- Describe the types and amount of clinical data that may be needed to obtain biosimilar approval.
- Introduce the proposed biosimilar approval process.
- Address questions related to the opportunity for obtaining marketing exclusivity.
Areas Covered in the Seminar:
- FDA's regulation of biosimilars.
- The process and requirements for demonstrating biosimilarity
- The February 2012 FDA Guidance Documents on Biosimilars
- Quality Considerations for demonstrating biosimilarity
- Safety Consideration for demonstrating biosimilarity
- The process of obtaining biosimilar approval
Who Will Benefit:
- Regulatory Affairs Professionals
- Managers
- Consultants
- Scientists
- Research Analysts
- State Policy Officials
- Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists
- Biologic and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Distributors, and Generic Firms
- Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries
Course Provider
Karl M. Nobert,
