FDA Issues Final Rule Expanding Availability of Insulin Products

The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market.

The final rule clears the way for the agency’s March 23 transition of filings for chemically synthesized polypeptides, including insulin products, from new drug applications to biologics license applications.

The FDA anticipates that the change will add more choices for patients and potentially reduce insulin prices. The final rule “will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition,” said FDA Commissioner Stephen Hahn.