FDA Releases Q&A for Industry With Details About Insulin Transition

The FDA Wednesday released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.

The nonbinding final industry guidance, “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers” represents the FDA’s current thinking as it implements the “transition” provision of the of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The document aims to facilitate transition planning and describes FDA’s compliance policy for the labeling of biological products that are the subject of deemed biologics license applications (BLAs). Besides insulin, other biological products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins.

An application for a biological product previously approved under section 505 of the Federal Food, Drug, and Cosmetic Act will change on March 23 and will be deemed to be a license for the biological product under section 351 of the Public Health Service (PHS) Act. Last month, the FDA issued a final rule on the definition of the term “biological product.” The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

The document lays out certain exceptions to the transition period and also how such products will be identified.

The BPCIA is “silent regarding the process for accomplishing the transition of approved NDAs to deemed BLAs,” the document noted. The FDA intends to send a letter to those application holders on March 23 advising that the approved NDA was deemed to be a BLA at 12:00 am Eastern Daylight Time on March 23 and no longer exists as an NDA.

If the NDA is approved on March 23, the approved NDA will be deemed to be a BLA immediately after approval.

Three questions address situations of particular interest to developers:

• One discusses where an applicant might, or might not, be able to use the FDA’s finding of safety, purity, and potency for another licensed biological product. For the most part, an applicant cannot rely on data from another product.
• Another discusses if a biological product approved in an NDA that is deemed to be a 351(a) BLA on the transition date can later be a “reference product” for a proposed biosimilar or interchangeable product.
• And another discusses when the application holder for a biological product that is the subject of a deemed 351(a) BLA can seek a determination of biosimilarity or interchangeability under section 351(k) of the PHS Act to another biological product licensed under section 351(a) of the PHS Act.

The document addresses things like application numbers, license numbers, program fees, withdrawals of applications, and labeling requirements. It also discusses supplements to applications, including changes to manufacturing sites, comparability data, batch analysis data, appropriate stability data, and facility inspections.

It also includes information about the transition from the Orange Book to the Purple Book and about the designation of proper names.