Regulatory Focus™ > News Articles > 2019 > 9 > FDA Compiles List of NDAs Transitioning to BLAs Next March

Regulatory NewsRegulatory News
Posted 24 September 2019 | By Zachary Brennan 

FDA Compiles List of NDAs Transitioning to BLAs Next March

The US Food and Drug Administration (FDA) on Tuesday released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020.

The shift is caused by the Biologics Price Competition and Innovation Act of 2009, which clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide).”

According to draft guidance released last December, FDA interprets the term “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” And FDA said it interprets the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that “(1) is made entirely by chemical synthesis and (2) is greater than 40 amino acids, but less than 100 amino acids in size.”

The change effectively means that any follow-on products for these NDAs will need to win approval as biosimilars. Former FDA Commissioner Scott Gottlieb previously explained how this shift will allow for the introduction of cost-saving insulin biosimilars, although senators questioned whether this transition period will briefly halt companies from seeking to bring insulin competition to market.

To enhance transparency and facilitate planning for the transition next March, FDA has compiled a preliminary list of approved biologics under the FD&C Act that are listed in FDA’s Orange Book and that will be affected by this transition provision.

The list of almost 100 products, current as of 31 August, mostly includes different insulins, but also includes products containing chorionic gonadotropin, follitropin alfa, hyaluronidase, menotropins, pancrelipase and somatropin, among others.

“This updated preliminary list includes certain administratively closed applications that are related to approved applications for biological products on the previous version of this list,” the agency added.

Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020 (current as of August 31, 2019)


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found