> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Unlikely to Follow Court’s BPCIA Implementation: Attorney
- URL: https://www.fdaweb.com/fda-unlikely-to-follow-courts-bpcia-implementation-attorney/
- Published: 2016-07-21T12:00:00.000Z
- Updated: 2026-09-14T21:16:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136244

Attorney **Nathan Beaver** (Foley & Lardner) says that FDA is unlikely to implement a biosimilar approval process laid out by the Federal Circuit Court of Appeals in *Amgen v. Apotex*. In an online *National Law Review* [post](http://www.natlawreview.com/article/can-fda-implement-biologics-price-competition-and-innovation-act-federal-circuit?ref=fdaweb.com), Beaver says that the court interpreted a provision in the Biologics Price Competition and Innovation Act (BPCIA) requiring an applicant to provide a reference-product sponsor with 180-days’ post-licensure notice before commercial marketing begins to mean that FDA could approve a biosimilar six months before the effective date of the approval.

According to the post. Apotex argued that a blanket application of the 180-day notice requirement would prolong the originator’s 12-year exclusivity period by six months, which was not the statute’s intent. The court responded “We have been pointed to no reason that FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date ….”

Beaver says that while this may seem like a simple suggestion by the court, it overlooks the fact that FDA has never given early approval for a license before a license’s effective date and may not have the authority or the mechanism to do so. He notes that the two biosimilar approvals to date were each long after the original licensed product’s 12-year exclusivity period had expired, so that the court’s recommended process did not apply

For FDA to be able to grant an early approval with a later effective date, Beaver writes, it probably would have to either **(1)** initiate a long rule-making process to create a mechanism to grant pre-effective date approvals for biosimilar applications; or **(2)** begin to grant pre-effective date approvals for biosimilar licenses without any regulations in place.

The first option would not be timely, he says, because the rulemaking would likely take years and there is no guarantee that the final approved mechanism would resemble what the court envisioned. The second option also is not realistic because it seems likely that if FDA were to grant a pre-effective date approval without regulations in place, it would be sued by the original license holder.

“Even if a pre-effective date approval mechanism is the correct ‘solution’ to the ‘problem’ of the BPCIA’s requirement for 180 days’ post-licensure notice before commercial marketing,” Beaver concludes, “it is unlikely to be implemented by FDA. No language in the statute expressly authorizes FDA to grant approval of a biosimilar product before the product’s license date is effective. While such authority might be found under a broad reading of the statute, a long rule-making process would prevent FDA from immediately implementing a pre-effective date approval mechanism, and FDA is unlikely to proceed without regulations in place. FDA also may be reluctant to adopt the court’s suggested approach because it would create additional administrative burdens on the government. Indeed, it appears that the court proposed an implementation of FDA’s authority under the BPCIA without regard to statutory limitations on the scope of FDA’s regulatory mandate as intended by Congress or FDA’s actual practices.”