As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
Applications for biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins, will be deemed to be a license under the Public Health Service Act starting on March 23, 2020. According to the agency, the change enables submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. A press release notes, “The transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition. The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing costs of insulin products.”
FDA has been preparing for the transition, and on Feb. 20, 2020, the agency published a final rule amending the regulation that defines a biological product in order to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020. The rule also clarifies the interpretation of the term “protein” to mean “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.” According to FDA, these changes will balance innovation and competition and allow for the development of biosimilars and interchangeable products, which will help keep the market competitive and give patients access to affordable treatments.
FDA also published a question and answer (Q&A) document for patients and a separate Q&A document for healthcare providers. The Q&A documents explain how the transition affects both groups and clarifies that the change should not affect existing prescribing or dispensing practices. The agency emphasized in the news release that patients should not see any difference in their medications.