The Food and Drug Administration is recommending that biosimilar labels carry the clinical data gathered by the product the biosimilar is intended to emulate. Biosimilars are derived from living organisms, and therefore may not be identical to brand-name drugs.
Federal regulators are likely trying to make it easier for physicians to understand the products' efficacy and safety by allowing biosimilars to use the clinical data that supported the reference product's approval. By definition, a biosimilar product has no clinically meaningful difference from its referral product in terms of safety, purity and potency.
Although the FDA notes that the labeling does not need to be identical to information on the reference product, biologic manufacturers will likely take issue with competitors using their data. A spokesman for the Biotechnology Industry Organization, which represents biologics manufacturers and other biotech companies, said the group was reviewing the guidance and could not yet comment.
Siegmund Gutman, chairman of the life sciences patent practice at law firm Proskauer, said the FDA is dealing with biosimilars in the same way it established regulations for generic drugs, which typically have identical labels to their name-brand counterparts, as required by patient-safety laws. The draft guidance last week is open for comment for 60 days.