FDA accepts Novartis' BLA for biosimilar rituximab

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted for review a BLA for GP2013, its proposed biosimilar of Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). Sandoz did not disclose the user fee action goal date or the indications for which it is seeking approval. Sandoz submitted the BLA under the 351(k) abbreviated approval pathway under the Biosimilar Price Competition and Innovation Act (BPCIA)...