Today, FDA released Draft Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations. This draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies, including considerations for the development of a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 The draft guidance is intended to assist applicants in demonstrating that a proposed product is biosimilar to a reference product under section 351(k) of the PHS Act.
This draft guidance revises the guidance entitled, “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,” published on April 30, 2015. FDA has adjusted the title of this draft guidance to more clearly communicate that this draft guidance includes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.
This draft guidance fulfills an important Biosimilar User Fee Act (BsUFA) II commitment and supports a key Biosimilar Action Plan (BAP) action to publish a revised draft guidance to provide additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity, in addition to 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 This draft guidance is intended to support the efficient development of biosimilars without compromising the Agency’s rigorous scientific standards or evidentiary criteria for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 high-quality therapeutic protein products.
For more information on how to submit comments on the draft guidance, please see the Federal Register Notice.