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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
Related News:- Dr. Reddy's Subsidiary Aurigene Stops Clinical Development of AUR-101 for the Treatment of Psoriasis
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.