No 12 Years Exclusivity In Biologics NDA-To-BLA Switch
This article was originally published in Scrip
Even though the Biologics Price Competition and Innovation Act (BPCIA) – the law that permitted the FDA to approve biosimilars – has been in place since March 2010, it's taken the agency six years to figure out how to implement the so-called "deemed to be a license" provision, which sets a deadline for regulators to stop approving biologics through certain pathways created under the Food, Drug and Cosmetic Act (FDCA).
In a new draft guidance document posted online on March 11, the FDA laid out a new plan for moving protein products, like insulin and insulin analogues, human growth hormone, pancreatic enzymes and follitropin, which have been approved for the US market through the FDCA pathways – new drug applications (NDAs), abbreviated new drug applications (ANDAs) or 505(b)(2) NDAs – to the biologics license application (BLA) process.
Although the majority of therapeutic biological products have been licensed under the Public Health Service (PHS) Act, some of the less complex protein products historically have been approved under the FDCA.
The BPCIA, however, changed the statutory authority under which protein products will be regulated by amending the definition of a "biological product" in the PHS Act to include a "protein, except any chemically synthesized polypeptide."
But for any companies assuming that when their products move from an NDA to a BLA pathway that the firms would gain an added 12 years of exclusivity protection – like brand-name biologics currently have against biosimilars – forget about it.
"Nothing" in the BPCIA, regulators said, suggests Congress intended to grant biologicals approved under the FDCA – some of which were cleared for the market decades ago – the same 12-year period of exclusivity protection on being 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, "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 try to sue the FDA to gain that added 12 years.
"Any time the FDA interprets what Congress intended, you can get disagreement," Cerwinski said.
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 March 23, 2020.
And, regulators pointed 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 able to be approved.
The FDA, however, said 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, he said.
So the FDA issued the draft guidance – noting it in January as among the more than 100 pending documents the agency planned to get out 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.