Government Spending Bill Tweak Means 3 More NDAs Will Become BLAs, FDA Says

Regulatory NewsRegulatory News
| 15 January 2020 | By Zachary Brennan 

As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the recently passed government spending bill included a further tweak to add new proteins to the transition.

The NDA to BLA change effectively means that any follow-on products for these NDAs will need to win approval as biosimilars after March. The transition was created 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).”

However, the latest appropriations bill, enacted in December, further amended the definition of “biological product” to remove this parenthetical “(except any chemically synthesized polypeptide).”

To help sponsors prepare for the transition, the US Food and Drug Administration (FDA) on Wednesday updated its list of products making the transition to include three more because of these changes from Congress. The list also added one additional NDA.

The NDA list now includes Ferring Pharmaceuticals’ Cushing’s syndrome treatment Acthrel (corticorelin ovine triflutate), Pfizer’s topical ointment Elase-chloromycetin (fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol), Theratechnologies’ excess stomach fat drug for HIV patients Egrifta (tesamorelin acetate) and Sanofi’s diabetes treatment Adlyxin (lixisenatide). FDA told Focus that Achthrel, Adlyxin and Egrifta were the three added because of the spending bill.

More than 90 other products are included in FDA's list.

The public may submit comments on this list and the draft guidance, “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” before 19 February to the public docket at Docket No. FDA-2015-D-4750.

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

Editor's note: Updated on 1/16 with FDA comment on the three added because of the government spending bill.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy