HYDERABAD: Pharma biggie Dr Reddy’s Laboratories Ltd on Monday stated the European Medicines Company’s (EMA) committee for medicinal merchandise for human use (CHMP) has really useful its proposed Rituximab biosimilar candidate — Ituxredi — for the European markets.
The EMA CHMP has adopted a constructive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based firm stated in a regulatory submitting.
Dr Reddy’s Ituxredi is a generic model of Roche’s MabThera that’s used for the remedy of non-Hodgkin’s lymphoma, persistent lymphocytic leukaemia, rheumatoid arthritis, Wegener’s granulomatosis, amongst others.
The CHMP constructive opinion will now be reviewed by the European Fee (EC)as a part of the established approval course of, and a call on granting the advertising and marketing authorisation in EU member nations and European Financial Space (EEA) member states similar to Norway, Iceland, and Liechtenstein could be taken after this, it stated.
Dr Reddy’s stated a advertising and marketing authorisation software (MAA) submission can be made individually to the UK Medicines and Healthcare merchandise Regulatory Company (MHRA) in line with the reliance route underneath the Worldwide Recognition Process (IRP).
The corporate had earlier obtained the EU GMP certificates for its Rituximab drug substance and drug product manufacturing facility in Hyderabad.
The EMA CHMP has adopted a constructive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based firm stated in a regulatory submitting.
Dr Reddy’s Ituxredi is a generic model of Roche’s MabThera that’s used for the remedy of non-Hodgkin’s lymphoma, persistent lymphocytic leukaemia, rheumatoid arthritis, Wegener’s granulomatosis, amongst others.
The CHMP constructive opinion will now be reviewed by the European Fee (EC)as a part of the established approval course of, and a call on granting the advertising and marketing authorisation in EU member nations and European Financial Space (EEA) member states similar to Norway, Iceland, and Liechtenstein could be taken after this, it stated.
Dr Reddy’s stated a advertising and marketing authorisation software (MAA) submission can be made individually to the UK Medicines and Healthcare merchandise Regulatory Company (MHRA) in line with the reliance route underneath the Worldwide Recognition Process (IRP).
The corporate had earlier obtained the EU GMP certificates for its Rituximab drug substance and drug product manufacturing facility in Hyderabad.
