NE HEALTH BUREAU
CHENNAI, SEPT 21
Biocon has achieved a significant regulatory milestone in the development of biosimilar therapies for breast cancer, with its Pertuzumab biosimilar becoming the first monoclonal antibody biosimilar to receive a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) under the regulator’s tailored clinical development approach.
Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited, announced on Monday that the CHMP has recommended the granting of marketing authorisation for its Pertuzumab biosimilar, Pebrilzo®, a 420 mg concentrate solution for infusion, for the treatment of HER2-positive breast cancer across multiple disease stages.
- European Medicines Agency’s CHMP recommends marketing authorisation for Pebrilzo® in HER2-positive breast cancer
- Milestone marks first positive CHMP opinion for a monoclonal antibody biosimilar under EMA’s tailored clinical development approach
- Biocon says advanced analytical and clinical pharmacology evidence reflects evolving biosimilar science and regulatory confidence
- European Commission to take final decision; product is not yet authorised for use in the EU
The positive opinion follows the review of the marketing authorisation application submitted by Biocon Biologics Ireland Limited, formerly Biosimilar Collaborations Ireland Limited, an indirect wholly-owned subsidiary of Biocon Biologics Limited.
Advancing biosimilar science, expanding treatment access
Shreehas Tambe, CEO and 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.”
The recommendation represents a regulatory development for Biocon’s biosimilar programme and highlights the role of advanced analytical and clinical pharmacology evidence in establishing biosimilarity under the EMA’s tailored clinical development approach.
European Commission to take final call
The European Commission will now undertake the final review of the application and issue its decision on marketing authorisation.
Following a positive decision, the Summary of Product Characteristics (SmPC) will be made available in all official European Union languages. The European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.
Biocon clarified that Pebrilzo® is not yet authorised for use in the European Union. Marketing authorisation must first be granted by the European Commission before the product can be used in the EU.
