In biologics regulation, which designation corresponds to biosimilars seeking licensure as biosimilar products?

• A. 351(a)
• B. 510(k)
• C. 505(b)(2)
• D. 351(k)

Answer: (D)

The concept here is that biosimilars use a specific abbreviated licensure route designed for products intended to be similar to an already licensed biologic. This pathway is designated under 351(k). It is built to show that the biosimilar is highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency, based on a stepwise package of analytical, nonclinical, and clinical data. This contrasts with a traditional biologics license under 351(a), which is for a novel biologic, and with the 510(k) path for devices or the 505(b)(2) NDA route used for certain small molecules with partial reliance on existing data. So for biosimilars seeking licensure as biosimilar products, the 351(k) designation is the appropriate and specific pathway.