Dr Reddy’s biosimilar cancer drug closer to gets EU nod
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Hyderabad: Dr Reddy’s Laboratories Ltd on Monday said the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI ) in European markets.
A press release from the city-based drug maker said as part of the established approval process, the CHMP’s positive opinion will now be reviewed by the European Commission, following which a decision will be made on the grant of marketing authorisation in the European Union member countries, and the European Economic Area member states of Norway, Iceland, and Liechtenstein.
Dr Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad.
A Marketing Authorisation Application for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure, the release said. DRL_RI is being developed as a biosimilar of Roche’s MabThera (Rituximab) which is approved for treatment of certain cancers in the USA, Europe and other countries.
