As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members of the biotechnology industry, filed an amicus brief in support of Amgen.
The brief argues that the information disclosure provision of subsection (l)(2)(A) and the 180-day notice provision of subsection (l)(8)(A) of the BCPIA are both mandatory, and the 180-day notice must follow FDA approval. BIO’s argument focuses primarily on the structure of the BCPIA and its legislative history, especially language in earlier drafts rejected by Congress. The brief also argues that any delays in commercial launch caused by the notice provision can be prevented if biosimilar manufacturers file their applications well in advance of the expiration of the reference product’s 12-year data exclusivity period and the FDA is able to grant tentative approval more than 180-days before exclusivity expires.
Stay tuned to Big Molecule Watch for further updates on this case.
