Statement on the U.S. Food and Drug Administration (FDA) Draft Guidance on Biosimilar Labeling

Pfenex is pleased the U.S. Food and Drug Administration (FDA) has fulfilled its commitment to publish draft guidance related to biosimilar product labeling. The draft guidance is an incremental step toward the development of a robust biosimilars market in the U.S. However, there are potential areas for improvement to ensure patients and providers understand that the biosimilar product is as safe and effective as the reference drug.

The draft FDA guidance recommends that, in the biosimilar product label, applicants incorporate relevant data and information from the reference product labeling with appropriate product-specific modifications, without further need for biosimilar specific product description. This guidance directly aligns with the FDA’s articulations on biosimilar development. A clinical study supporting the licensure of the biosimilar product generally would serve to support a demonstration of no clinically meaningful differences between the proposed biosimilar product and the reference product for the approved indications. As such, Pfenex believes these guidance recommendations support the formation of a robust biosimilars marketplace.

The draft guidance also proposes a “statement of biosimilarity” to distinguish a biological product as biosimilar to a reference product in the “Highlights” section of the label. Pfenex is concerned that calling out a product as biosimilar to another in this way could confuse patients and providers as to whether they are receiving the treatment prescribed. Without sufficient patient and provider education around biosimilar safety and efficacy, this statement of biosimilarity could undermine confidence in the biosimilar product, which could hinder market development, and uptake. As biosimilars have no clinically meaningful differences from the reference product, the footnote would only serve to diminish, rather than clarify, the FDA’s notation that the pathway to approval does not impact the safety and efficacy of a given product.

Finally, the draft guidance does not provide recommendations for the labeling of interchangeable biosimilar products, explaining that interchangeability guidance is forthcoming. We eagerly await this much-needed guidance which is a key component to providing biosimilar manufacturers with a clear framework for presenting biosimilar packages to the Agency for review.