Biocon Biologics’ pertuzumab biosimilar gets EU CHMP backing

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed EU marketing authorization for Biocon Biologics’ pertuzumab biosimilar Pebrilzo for HER2-positive breast cancer. The European Commission will issue the final decision, and the drug cannot be marketed in the EU until authorization is granted. Pebrilzo is positioned as the first monoclonal antibody biosimilar to win a CHMP recommendation under the EMA’s tailored clinical approach.