Dr. Reddy’s Laboratories Ltd announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its proposed biosimilar Rituximab candidate, DRL_RI (ITUXREDI), for the European market.
The positive opinion is a key step in the approval process and will now be reviewed by the European Commission. The Commission will then decide on granting marketing authorization in the European Union member countries, as well as the European Economic Area member states, including Norway, Iceland, and Liechtenstein.
Dr. Reddy’s has already secured the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility in Hyderabad.
As reported by money.rediff.com, additionally, a separate Marketing Authorisation Application will be submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) through the reliance route under the International Recognition Procedure.