Biocon Biologics gets positive CHMP opinion for Pebrilzo HER2 biosimilar
Biocon Biologics just got a big thumbs-up from the European Medicines Agency (EMA) for Pebrilzo, its biosimilar treatment for HER2-positive breast cancer.
This means Pebrilzo is one step closer to being available across the EU, but it still needs final approval from the European Commission.
Notably, it is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's new tailored clinical development approach.
Pebrilzo could expand EU treatment options
Pebrilzo is designed to be used with other treatments like Trastuzumab and chemotherapy for different stages of HER2-positive breast cancer.
Biocon's Shreehas Tambe, CEO & Managing Director, called this a major step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe.
If the last approval comes through, patients could soon have another important option for care.