HYDERABAD: Pharma biggie Dr Reddy’s Laboratories Ltd on Monday said the European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended its proposed Rituximab biosimilar candidate — Ituxredi — for the European markets.
The EMA CHMP has adopted a positive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based company said in a regulatory filing.
Dr Reddy’s Ituxredi is a generic version of Roche’s MabThera that is used for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, Wegener’s granulomatosis, among others.
The CHMP positive opinion will now be reviewed by the European Commission (EC)as part of the established approval process, and a decision on granting the marketing authorisation in EU member countries and European Economic Area (EEA) member states such as Norway, Iceland, and Liechtenstein would be taken after this, it said.
Dr Reddy’s said a marketing authorisation application (MAA) submission will be made separately to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in keeping with the reliance route under the International Recognition Procedure (IRP).
The company had earlier received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility in Hyderabad.
The EMA CHMP has adopted a positive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based company said in a regulatory filing.
Dr Reddy’s Ituxredi is a generic version of Roche’s MabThera that is used for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, Wegener’s granulomatosis, among others.
The CHMP positive opinion will now be reviewed by the European Commission (EC)as part of the established approval process, and a decision on granting the marketing authorisation in EU member countries and European Economic Area (EEA) member states such as Norway, Iceland, and Liechtenstein would be taken after this, it said.
Dr Reddy’s said a marketing authorisation application (MAA) submission will be made separately to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in keeping with the reliance route under the International Recognition Procedure (IRP).
The company had earlier received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility in Hyderabad.
