The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a ‘positive’ opinion recommending the launch of Dr. Reddy’s Laboratories’s proposed biosimilar Rituximab candidate in European markets.
Hyderabad-based Dr Reddy’s previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility.
As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein, the company said in a release.
A Marketing Authorisation Application (MAA) 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 (IRP).
Rituximab drug candidate is being developed as a biosimilar of MabThera (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. It is a proposed biosimilar to reference medicinal product MabThera and the intended indications are the same as those currently approved for MabThera. They include Non–Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) and Pemphigus Vulgaris (PV).
EMA reference product, MabThera, is a registered trademark of Roche.