A Biosimilars FDA Catch-22
Foley & Lardner's recent PharmaPatents blog highlights a catch-22 position for the FDA under the US Federal Circuit Court decision Amgen vs Apotex on the 180 day notice provision of the biosimilars provisions. The Court ruled that an applicant for FDA approval of a biosimilar must provide the originator 180 days notice before marketing can begin. The Court said this did not extend the 12 year biologics exclusivity of the originator by 180 days (6 months) because the FDA could give approval before the exclusivity runs out, to take effect when the exclusivity runs out. But the FDA has never given advance notice of an approval.
The FDA seems to have two bad options: Take a long time or get sued!
"Neither the Federal Food, Drug, and Cosmetic Act nor the Public Health Service Act explicitly grants the FDA authority to issue an approval that is effective at a later date. Rather, the statutes appear to be silent on this issue. Accordingly, it seems that the FDA would have to exercise one of two options to effectuate the court’s suggestion:
- Initiate a long rule-making process to create a mechanism to grant pre-effective date approvals for biosimilar applications
2. Begin to grant pre-effective date approvals for biosimilar licenses without any regulations in place.
The first option would not be timely. The rule-making process likely would take years, and there is no guarantee that the final approval mechanism would resemble what the court envisioned.
The second option also is not realistic. If the FDA were to grant a pre-effective date approval without regulations in place, it likely would be immediately sued by the original license holder. Additionally, the FDA historically has been uncomfortable taking any action that is inconsistent with FDA approval policies and procedures for other products."
https://www.pharmapatentsblog.com/2016/07/21/can-fda-implement-the-bpcia-as-the-cafc-suggested/
This will be fun to watch.
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