Biocon Biologics 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 a Marketing Authorisation (MA) to its pertuzumab biosimilar as 420 mg concentrate solution for infusion, under the brand name Pebrilzo, for the treatment of HER2?positive breast cancer across multiple disease stages.

The positive opinion follows the review of the MA application submitted by Biocon Biologics Ireland (formerly Biosimilar Collaborations Ireland), an indirect wholly-owned subsidiary of Biocon Biologics.

Shreehas Tambe, CEO and MD, 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 (EC) will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be available in all official European Union (EU) languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.

Until MA is granted by the EC, the product is not authorised for use in the EU.

Pebrilzo is a biosimilar medicinal product and the active substance is Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the Human Epidermal Growth Factor (HEGF) receptor 2 (HER2), inhibiting the proliferation of tumor 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.

In addition, it 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.

Extensive orthogonal, state-of-the-art structural and functional analytical characterisation, together with comparative clinical pharmacokinetic data, demonstrated that Pebrilzo, a Pertuzumab biosimilar, is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety, or efficacy.