With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs).
The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
So far, all 26 of the biosimilars approved in the U.S reference biologics that are administered by health care providers, so interchangeability, with its automatic substitution at the pharmacy, hasn’t been put to the test. But as insulins and other deemed biologics give rise to biosimilars, companies developing the follow-ons may seek interchangeability labeling, which will let them market their copies more like a generic.
“This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace," FDA Commissioner Stephen Hahn said. "These critical therapies often carry a heavy price tag. … Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs.”
In preparing for the new seascape, the FDA released a final rule Thursday that defines a “biological product.” It also issued two frequently asked questions (FAQ) documents providing patients and health care providers with information about the transition.
Reflecting a change made by the fiscal 2020 federal spending bill that was passed in December, the rule codifies the FDA's interpretation of "protein" to mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. Scheduled for publication in the Feb. 21, 2020, Federal Register, the rule will become effective March 23 when the NDAs are deemed as BLAs in accordance with the 2010 Biologics Price Competition and Innovation Act.
Both FAQs explain why the transition is taking place. The FAQ for patients assures them that the deeming will have no impact on their prescriptions other than encouraging more competition. Doctors also will see little change. However, those who use the FDA’s Orange Book to get information about an NDA will have to turn to the Purple Book listing of approved biologics for the deemed products, as the FDA said it plans to transfer those drugs to the Purple Book March 23 or shortly thereafter.
Once competition hits, doctors also will have to familiarize themselves with biosimilar choices and which “brands” a patient’s insurance will cover. But that competition won’t be immediate. Although several companies reportedly are developing biosimilars referencing various insulin products, they can’t submit a BLA for their products until March 23. Then it could take up to 12 months for the FDA to approve a biosimilar or provide a complete response, the agency said in its FAQ for health care providers.