Recommendation issued under EMA’s tailored clinical development approach
Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of marketing authorisation for its Pertuzumab biosimilar, Pebrilzo®, as a 420 mg concentrate solution for infusion.
The biosimilar is intended for the treatment of HER2-positive breast cancer across multiple disease stages. 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.
According to Biocon, Pebrilzo® is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical development approach.
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.”
The European Commission will now undertake the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be made available in all official European Union languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.
Until marketing authorisation is granted by the European Commission, Pebrilzo® is not authorised for use in the European Union.
About Pebrilzo®
Pebrilzo® is a biosimilar medicinal product containing Pertuzumab as its active substance. Pertuzumab is a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2.
The product is indicated for use in combination with Trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence. It is also indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
In addition, Pebrilzo® is indicated for use in combination with Trastuzumab and Docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Biocon stated that extensive orthogonal, state-of-the-art structural and functional analytical characterisation, together with comparative clinical pharmacokinetic data, demonstrated that Pebrilzo® is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety or efficacy.
The positive CHMP opinion represents a regulatory milestone in the development of Biocon’s Pertuzumab biosimilar, while the product remains subject to the European Commission’s final marketing authorisation decision.