CHMP issues favorable recommendation for Omnitrope
It’s about time, but never too late for Sandoz to celebrate the approval of the GH “biosimilar” known as Omnitrope. The CHMP opinion is the required precursor to EC approval. If approved, Omnitrope will be the European Union’s first approval since biosimilar guidelines were issued there over a year ago. In the U.S., Sandoz (parnet Novartis) is suing FDA to advance action on the 505(b)(2) NDA for the drug. FDA guidance for accelerated approval pathways for recombinant drugs is expected later this year.
