FDA Releases Draft Guidelines for Biosimilar Development Approval
FDA to Hold Hearing for Public Comments on the Draft Guidelines for Biosimilar Development Approval
The Food and Drug Administration ("FDA") has announced a 1-day public hearing to obtain input on the recently issued draft guidelines for biosimilar development approval. The FDA will consider the information it obtains from the public hearing when finalizing these draft guidelines. In addition, the FDA is soliciting public input regarding topics for future policies concerning biosimilar products.
The hearing is scheduled for 8:30 a.m. on May 11, 2012, at the FDA’s White Oak Campus. Seating will be on a first-come first-served basis and those individuals wishing to speak must register by e-mail to
The draft guidelines include:
These draft guidelines are intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application (called a “351(k)” application) to the FDA. According to the FDA, it intends to use a risk-based “totality-of-the-evidence” approach to evaluate the data and information submitted in support of a determination of biosimilarity. The FDA recommends a stepwise approach to demonstrating biosimilarity, which can include comparisons between the proposed product and the reference product with respect to structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.
Part of the biosimilar assessment is determining whether the proposed product is highly similar to a reference product. The FDA provides guidance on the analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes the importance of extensive analytical, physicochemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components. The FDA notes that these draft guidelines are "not intended to provide an overview of FDA’s approach to determining interchangeability because FDA is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product.”
The FDA provides answers to common questions from people interested in developing biosimilar products. The FDA hopes to “promote transparency and facilitate development programs for proposed biosimilar products” through the question and answer format. In particular, the FDA addresses questions that may arise in the early stages of product development, such as how to request meetings with the FDA, addressing differences in formulation from the reference product, how to request exclusivity, and other topics.
Additionally, the FDA is requesting written public comment on the draft guidelines. Procedures for commenting have been published in the Federal Register.
© 2012 Perkins Coie LLP