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# Apotex Appeals Court Biosimilar Ruling
- URL: https://www.fdaweb.com/apotex-appeals-court-biosimilar-ruling/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134363

> Apotex is asking the Federal Circuit Court of Appeals to review a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. A *Big Molecule Watch* blog [post](http://www.bigmoleculewatch.com/2016/01/05/update-in-amgen-v-apotex-apotexs-opening-brief-at-the-federal-circuit/?ref=fdaweb.com) says that Apotex is arguing that because the two parties completed the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” before the lawsuit was filed, a notice of commercial marketing is not required. Apotex says that the Amgen suit against it is different from *Amgen v. Sandoz*, in which Sandoz chose not to participate in the patent dance and was required to provide 180 days’ notice of commercial marketing.  
>  
> Apotex also argues in its appeal that making the 180-day notice period mandatory in all cases, rather than only in cases when the biosimilar applicant chooses not to participate in the patent dance, would amount to a *de facto* extension of the 12-year exclusivity period provided under the BPCIA.