Biocon Gets Positive CHMP Opinion for Pertuzumab Biosimilar Pebrilzo in HER2-Positive Breast Cancer
New Delhi: Biocon Biologics Limited has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the granting of marketing authorisation for its pertuzumab biosimilar, Pebrilzo, for the treatment of HER2-positive breast cancer across multiple disease stages.
The product is a 420 mg concentrate solution for infusion. 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.
Shreehas Tambe, CEO and Managing Director, Biocon, said the positive CHMP opinion marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe.
He added that the product is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's tailored clinical development approach, describing it as a milestone in the evolution of biosimilar science and regulatory confidence in advanced analytical and clinical pharmacology evidence for establishing biosimilarity.
The European Commission will now conduct the final review of the application and issue its decision. Until marketing authorisation is granted by the European Commission, Pebrilzo is not authorised for use in the European Union.
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.
Pebrilzo is a biosimilar medicinal product containing pertuzumab, 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.
It 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, as well as in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
It is also indicated in combination with trastuzumab and docetaxel for 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 Limited is a global biopharmaceutical company headquartered in Bengaluru, India. The company operates across biosimilars and generics, with a portfolio spanning areas including diabetes, oncology, obesity, cardiovascular diseases, immunology, ophthalmology and bone health.
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