FDA issues Draft Guidance for Industry on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations

FDA issues Draft Guidance for Industry on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations 

Today, FDA released Draft Guidance for Industry: “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations”. This draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies, including considerations for the development of a comparative analytical assessment plan using a stepwise approach, to support a demonstration of biosimilarity.  It also provides sponsors with recommendations on certain other aspects of the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed biosimilar product. The draft guidance is intended to assist applicants in demonstrating that a proposed product is biosimilar to a reference product under section 351(k) of the PHS Act.

Among other things, this guidance contains information on:

•  The design and evaluation of comparative analytical studies, including recommendations for developing a comparative analytical assessment plan intended to support a demonstration that a proposed product is biosimilar to a reference product;
• Updated recommendations for collection and analysis of comparative analytical similarity data, including information on the number of lots analyzed and on data analysis methods that can be used in lieu of the previously recommended statistical equivalence test;
• Aspects of the chemistry, manufacturing, and controls (CMC) portion (e.g., characterization, adventitious agent safety testing, process controls, specifications, and stability) of the marketing application needed to support a demonstration of biosimilarity; and
• The Agency’s continued receptiveness to considering alternative approaches proposed by sponsors for the analysis of analytical similarity data.

This draft guidance revises the final guidance entitled, “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,” published on April 30, 2015. It also includes a section that describes considerations for the design and evaluation of comparative analytical studies intended to support a demonstration of “highly similar” for biosimilar biological products. This content fulfills the Agency’s Biosimilar User Fee Act (BsUFA) II commitment to publish a revised draft or final guidance within 18 months after the close of the public comment period for the withdrawn draft guidance, “Statistical Approaches to Evaluate Analytical Similarity.”

This current draft guidance supports a key Biosimilar Action Plan (BAP) action to provide additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity, including by publishing revised draft guidance on the use of data analysis methods, including statistical approaches. This draft guidance is intended to support the efficient development of biosimilars without compromising the Agency’s rigorous scientific standards or evidentiary criteria for evaluating marketing applications for biosimilars.

Promoting an efficient pathway for the development and approval of biosimilar products supports FDA’s mission by maintaining the balance between encouraging innovation in drug development and facilitating robust market competition. Ultimately, these efforts may increase market competition among biological products, lowering costs for patients and payors, and expanding access to these products.

For more information on how to submit comments on the draft guidance and questions posed in the Notice of Availability, see the Federal Register notice.