Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars

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proposed regulation of biosimilars based on past Agency statements and information contained in its recently published draft Guidance Documents.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

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He focuses his practice on the representation and counseling of clients in the food and drug industry, including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine; and medical devices. He and his colleagues at Squire Sanders represent a number of clients who will be directly impacts by FDA’s proposed regulatory approach for biosimilars.

Topic Background:

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.”

For regulatory purposes, a biosimilar is defined as a biological product that is highly similar to or interchangeable with an existing biologic, notwithstanding minor differences, and for which there are no clinically meaningful differences in terms of the safety, purity, and potency. In addition to creating a regulatory approval pathway for such products, FDA also responded to a statutory absence, and established a 12 year limit on patent protection for these biologics.

The draft guidance documents published by FDA outline both quality and scientific considerations to be considered when demonstrating biosimilarity, and describe the regulatory procedures involved in submitting an application for a biosimilar product to FDA for approval. Two of the published guidance documents specifically address quality and scientific considerations for demonstrating biosimilarity. The third, a Questions & Answers guidance attempts to answer anticipated questions from applicants regarding biosimilarity or interchangeability; the filing and approval of applications; and marketing exclusivity. In publishing the guidance documents, it was FDA’s hope that the additional guidance would enhance competition in the marketplace by encouraging sponsors to create lower cost versions of currently approved biological products.

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