FDA accepts proposed biosimilar rituximab for review

The US Food and Drug Administration has accepted a Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan (rituximab) from Sandoz, the biosimilars and generics business of Swiss pharma giant Novartis (NOVN: VX).

Swiss pharma giant Roche’s (ROG: SIX) Rituxan, also marketed as MabThera, is used to treat blood cancers including non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

Under the trade name Rixathon, Sandoz’ rituximab biosimilar was approved by the European Commission in June this year. Celltrion Healthcare’s rituximab biosimilar Truxima was approved in Europe in February.