FDA Plans to End Switching Study Requirement for Biosimilars

The FDA is proposing to eliminate study requirements that demonstrate biosimilars are interchangeable with their reference drugs.

The draft guidance, published in the Federal Register on Friday, describes considerations regarding a “switching study,” or studies intended to support that a biological product is interchangeable with an FDA-licensed biological reference product.

A biosimilar is considered a product close enough to a biologic product used to treat patients in the same way, and interchangeable biosimilar products can be swapped out as a substitute for a biologic at the pharmacy counter. Removing the study requirement can save time and expenses for biosimilar ...