New Delhi: Biotechnology major Biocon on Monday said its wholly-owned subsidiary Biocon Biologics has received a positive recommendation from the European Medicines Agency's panel for its breast cancer biosimilar Pertuzumab.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation to the Pertuzumab biosimilar (420 mg concentrate solution for infusion) under the brand name Pebrilzo, the company said in a statement.
The product is indicated for treatment of HER2-positive breast cancer across multiple stages of the disease, it added.
The European Commission will now conduct the final review of the marketing authorisation application to take a decision on granting marketing approval for use across the European Union.
Biocon said its Pertuzumab biosimilar is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's new tailored clinical development approach.
"The positive CHMP opinion for our Pertuzumab biosimilar marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe," said Shreehas Tambe, CEO & Managing Director, Biocon.
The marketing authorisation application was submitted by Biocon Biologics Ireland Ltd, an indirect wholly-owned subsidiary of Biocon Biologics.
Pebrilzo is intended for use in combination with other therapies, such as Trastuzumab and chemotherapy, in adult patients with HER2-positive early, locally advanced, or metastatic breast cancer, the company said.
The product will not be authorised for use in the European Union until marketing authorisation is formally granted by the European Commission, it added.
