Dr. Reddy’s Reports BLA Acceptance for DRL_RI, a Proposed Biosimilar Rituximab by the US FDA, EMA and MHRA
Shots:
- The BLA for the proposed biosimilar rituximab DRL_RI has been accepted for review by the US FDA, EMA & MHRA. DRL_RI, a biosimilar of Rituxan/ MabThera (rituximab) was approved for various indications for adult patients with RA, NHL, CLL, pemphigus vulgaris, granulomatosis with polyangiitis & microscopic polyangiitis
- The full set of clinical studies has been completed for the proposed rituximab biosimilar DRL_RI to file in the US, EU & other regions
- Rituximab biosimilar was approved for marketing in India and ~25 emerging markets. Dr. Reddy is currently collaborating with its partner Fresenius Kabi to commercialize the proposed biosimilar of rituximab in the US, planning to commercialize the product in the EU & other geographies
Ref: Businesswire | Image: Dr. Reddy's
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