Dr. Reddy’s receives positive CHMP opinion from EMA for proposed rituximab biosimilar

Dr. Reddy’s shared that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the launch of its proposed biosimilar rituximab candidate in European markets. 

Dr. Reddy’s had previously received the EU GMP certificate for its rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission, following which a decision will be made on the grant of marketing authorization in the European Union member countries, and the European Economic Area member states of Norway, Iceland and Liechtenstein. 

A Marketing Authorization Application for submission to the UK Medicines and Healthcare products Regulatory Agency will be made separately in keeping with the reliance route under the International Recognition Procedure. 

[Read more: Dr. Reddy's acquires MenoLabs from Amyris]

DRL_RI is being developed as a biosimilar of Roche's MabThera (rituximab), a cluster of differentiation 20 directed cytolytic antibody. 

Ituxredi/DRL_RI (rituximab) is a proposed biosimilar to MabThera and the intended indications are the same as those currently approved for MabThera: non–Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis; pemphigus vulgaris.