Mumbai, Sept. 21 -- The opinion recommends marketing authorisation for Biocon Biologics' Pertuzumab biosimilar, which will be marketed under the brand name Pebrilzo. The product is a 420 mg concentrate solution for infusion intended to treat HER2-positive breast cancer across multiple disease stages.

The positive opinion follows the review of a marketing authorisation application submitted by Biocon Biologics Ireland, an indirect wholly owned subsidiary of Biocon Biologics.

Biocon said its Pertuzumab biosimilar is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's tailored clinical development approach. The company said the application was supported by structural and functional analytical charact...