Dr Reddy’s Labs to Launch Rituximab Biosimilar in Europe

Dr Reddy’s Laboratories announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the launch of its biosimilar Rituximab (DRL_RI) in European markets. The decision is pending review by the European Commission. A separate application will be submitted to the UK regulator.

Dr Reddy’s Laboratories Ltd announced on Monday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the proposed biosimilar Rituximab, branded as DRL_RI (ITUXREDI), paving the way for its launch in European markets.

According to a company press release, the CHMP’s positive recommendation will now go to the European Commission for review. A final decision on marketing authorization is expected soon, affecting the European Union member countries and the European Economic Area states including Norway, Iceland, and Liechtenstein.

Dr Reddy’s Laboratories, headquartered in Hyderabad, had previously secured the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility. Additionally, a Marketing Authorization Application will be submitted separately to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure.

The biosimilar DRL_RI is being developed as an alternative to Roche’s MabThera (Rituximab), which is already approved for the treatment of certain cancers in the USA, Europe, and other countries.