Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants
- Paul A. Calvo, Ph.D.
- Sterne, Kessler, Goldstein & Fox
In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a Citizens Petition requesting FDA require such disclosure. On March 25, 2015 FDA denied Amgen’s Petition.
In this alert, Paul A. Calvo, Ph.D. explains FDA's stance as stated in its denial of Amgen's Petition.