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The draft guidance, published in the Federal Register on Friday, describes considerations regarding a “switching study,” or studies intended to support that a biological product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 ...