No 12-Year Exclusivity In US FDA's NDA-To-BLA Switch
This article was originally published in SRA
The US Food and Drug Administration has published new draft guidance describing how it plans to take certain protein products that have been approved through Food, Drug and Cosmetic Act (FDCA) processes like the new drug application (NDA) pathway and move them over to the biologics license application (BLA) process1.
The move is necessary because although the majority of therapeutic biological products have been licensed under the Public Health Service (PHS) Act, some of the less complex protein products have historically been approved under the FDCA.
They include products like insulin and insulin analogues, human growth hormone, pancreatic enzymes and follitropin that have been approved for the US market through the FDCA pathways – NDAs, abbreviated new drug applications (ANDAs) or 505(b)(2) NDAs.
But the Biologics Price Competition and Innovation Act (BPCIA) – the 2010 law that permitted the FDA to approve biosimilars – changed the statutory authority under which protein products would be regulated by amending the definition of a "biological product" in the PHS Act to include a "protein, except any chemically synthesized polypeptide."
The BPCIA also laid down a 10-year transitional period at the end of which any approved applications for biological products under the FDCA would be "deemed to be a license for a biological product" under section 351 of the PHS Act.
The FDA's new draft guidance, posted online on March 11, describes the agency's approach to implementation of the "deemed to be a license" provision, under which, as of March 23, 2020, any biologicals that have been approved under the FDCA will no longer exist as NDAs or ANDAs and will be replaced by approved BLAs.
But any companies that assume that when their products move from an NDA to a BLA pathway they will gain an added 12 years of exclusivity protection – as brand-name biologics currently have against biosimilar competition – will be disappointed.
Nothing in the BPCIA suggests that Congress intended for biologicals approved under the FDCA – some of which were cleared for the market decades ago – to enjoy the same 12-year period of exclusivity protection when they are deemed to have a license under the PHS Act, the FDA contended.
In other words, said New York lawyer Robert Cerwinski, a partner in the intellectual property litigation group at Goodwin Procter LLP, "you don't get the 12-year exclusivity period by virtue of that conversion" from the NDA to the BLA.
The FDA's interpretation of the BPCIA in this case, Cerwinski told Scrip Regulatory Affairs sister publication Scrip Intelligence, "prevents an exclusivity windfall by simple operation of the statute."
Nonetheless, he said he "wouldn't be surprised" if some companies whose products were initially approved as NDAs tried to sue the FDA to gain that 12-year protection. "Any time the FDA interprets what Congress intended, you can get disagreement," Cerwinski said.
FDA's Interpretation Of BPCIA
Under the FDA's new interpretation of the BPCIA, as of March 23, 2020, applications for biologicals that have been approved under the FDCA will no longer exist as NDA or ANDAs and will be replaced by approved BLAs under section 351(a) or 351(k) – the biosimilar pathway – of the PHS Act. The FDA also will no longer approve any NDAs or ANDAs for biologicals after that date.
And, regulators point out in the new draft guidance document – "Implementation of the 'Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act" – any applications for protein products that have been submitted under the FDCA pathways, but are pending on March 23, 2020, will not be approvable. The FDA did say, though, that those applications could be withdrawn and resubmitted as BLAs or 351(k)s.
Even though Congress remained silent on implementation of the "license" provision, the FDA "knew it was going to have to do this transition for those products that were approved via an NDA or ANDA or 505(b)(2) NDAs to BLAs at some point because the BPCIA provided for that" – mandating the March 23, 2020 deadline, Cerwinski said.
But the agency also recognized that switch could be very disruptive for companies' regulatory programs and commercial launch plans, and so it issued the draft guidance, he noted. In January the agency identified the guidance as one of more than 100 pending documents the agency planned to get out of the door this year.
"I think they wanted to get ahead of this so stakeholders could plan accordingly and not waste a bunch of money and time," Cerwinski said.
While some biologics makers could very well get caught in the transition, "the FDA has now given them clear warning," he said, "and they better plan accordingly."
The FDA is taking comments over the next 60 days on its approach for implementing the "deemed to be a license" provision of the BPCIA.
References
- Draft FDA Guidance on Implementation of the "Deemed to be a License" Provision of the Biologics Price Competition and Innovation Act of 2009, March 2016, www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf
A version of this article has also been published inScrip Intelligence. Scrip Regulatory Affairs brings selected complementary coverage from our sister publications to our subscribers.