Biocon Biologics receives positive CHMP opinion for Pertuzumab biosimilar

Biocon Biologics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of a marketing authorisation to its Pertuzumab biosimilar as 420 mg concentrate solution for infusion, under the brand name Pebrilzo?, for the treatment of HER2-positive breast cancer across multiple disease stages.

The positive opinion follows the review of the marketing authorization application submitted by Biocon Biologics Ireland (formerly Biosimilar Collaborations Ireland), an indirect wholly-owned subsidiary of Biocon Biologics.

The European Commission will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be available in all official European Union languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.

Until marketing authorisation is granted by the European Commission, the product is not authorised for use in the European Union.