Biosimilars: BIO Comments on Scientific Considerations

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”(the Draft Guidance).

 BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. 

 Our comments below are grounded by the specific hands-on experience of BIO member companies, experience that is crucial to understanding biological products.  These answers are also consistent with BIO's long-standing Principles on Biosimilars, which state that any pathway for the approval of biosimilars must protect patient safety and preserve incentives to innovate.

 BIO appreciates that the issuance of this Draft Guidance, and the two other biosimilars guidances issued on the same day, is an important initial step in developing the regulatory framework for a biosimilars approval pathway.  We request that FDA draft product-specific guidances in the future.