Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation for its Pertuzumab biosimilar, Pebrilzo®, for the treatment of HER2-positive breast cancer.
The recommendation covers Pebrilzo® as a 420 mg concentrate solution for infusion and follows the review of the marketing authorisation application submitted by Biocon Biologics Ireland Limited, formerly known as Biosimilar Collaborations Ireland Limited, an indirect wholly-owned subsidiary of Biocon Biologics Limited.
Biocon said the Pertuzumab biosimilar is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA’s tailored clinical development approach. The regulatory pathway places greater emphasis on advanced analytical and clinical pharmacology evidence to establish biosimilarity.
Shreehas Tambe, CEO & Managing Director, Biocon, said, “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. As the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA’s tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity.”
Pebrilzo® contains Pertuzumab, a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2). It is proposed for use with Trastuzumab and chemotherapy in the neoadjuvant treatment of adults with HER2-positive locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence, and in the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
It is also indicated for use with Trastuzumab and Docetaxel in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. Biocon said extensive structural and functional analytical characterisation, along with comparative clinical pharmacokinetic data, demonstrated high similarity between Pebrilzo® and the reference biologic, with no clinically meaningful differences identified in quality, safety or efficacy. The European Commission will now conduct the final review and make a decision on marketing authorisation. Until that decision is granted, Pebrilzo® is not authorised for use in the European Union.
Biocon Limited is a global biopharmaceutical company headquartered in Bengaluru, focused on providing affordable medicines. Its portfolio spans biosimilars and generics across diabetes, oncology, obesity, cardiovascular diseases, immunology, ophthalmology and bone health. The company has commercialised 12 biosimilars and more than 30 generic formulations globally, with a pipeline of more than 20 biosimilar assets, GLP-1 peptides and complex generics. Biocon operates in more than 120 countries with seven manufacturing sites, three R&D sites, 18 offices and more than 9,500 employees.
