US Court of Appeal requires 180 day wait from FDA approval for Zarxio (filgrastim biosimilar) before launch in US- Sandoz

The US Court of Appeal for the Federal Circuit has ruled that Sandoz must wait 180 days from FDA approval of the biosimilar Zarxio (filgrastim biosimilar) before launching in the US (2 September 2015). Amgen, which markets Neupogen (filgrastim, the originator drug), had alleged that Sandoz had breached the Biologics Price Competition and Innovation Act by not disclosing manufacturing information to Amgen but but this allegation was rejected by the Court.

Comment: Zarxio was FDA approved as the first biosimilar in the US in March 2015 on the basis that it was “highly similar” to Amgen's innovator medicine Neupogen and that clinical data have demonstrated there are no “clinically meaningful differences” in safety, purity and potency between the products. Neupogen lost patent protection in the US in 2013. Zarxio is marketed as Zarzio in the EU and was approved in 2009.