Biocon Biologics Ltd, a wholly-owned subsidiary of Biocon Ltd, 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 product, available as a 420 mg concentrate solution for infusion, is proposed for use across multiple stages of HER2-positive breast cancer.
The positive CHMP opinion follows the review of a marketing authorisation application submitted by Biocon Biologics Ireland Ltd, formerly Biosimilar Collaborations Ireland Ltd, an indirect wholly-owned subsidiary of Biocon Biologics.
Milestone for biosimilar development
Biocon said Pebrilzo is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical development approach.
The approach places greater emphasis on advanced analytical and clinical pharmacology evidence to establish biosimilarity, potentially reducing the need for extensive clinical trials where analytical evidence can adequately demonstrate similarity to the reference biologic.
Shreehas Tambe, CEO & Managing Director, Biocon, said the positive opinion marks an important step towards expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe.
He said the decision also represents a milestone in the evolution of biosimilar science and regulatory confidence in analytical and clinical pharmacology evidence for establishing biosimilarity.
Multiple breast cancer indications
Pebrilzo contains Pertuzumab, a monoclonal antibody that binds to the HER2 receptor and inhibits the proliferation of tumour cells that overexpress HER2.
The proposed indications cover adult patients with HER2-positive breast cancer at different stages. These include neoadjuvant treatment, in combination with Trastuzumab and chemotherapy, for locally advanced, inflammatory or early-stage breast cancer where there is a high risk of recurrence.
The biosimilar is also proposed for adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
For HER2-positive metastatic or locally recurrent unresectable breast cancer, Pebrilzo is proposed for use with Trastuzumab and Docetaxel in patients who have not previously received anti-HER2 therapy or chemotherapy for their metastatic disease.
Biocon said extensive structural and functional analytical characterisation, along 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.
European Commission decision next
The CHMP opinion is a recommendation and does not itself authorise the product for use in the European Union.
The European Commission will now conduct the final review and issue its decision on marketing authorisation. If approved, the Summary of Product Characteristics will be made available in all official EU languages, while the European Public Assessment Report will subsequently be published on the EMA website.
Until the European Commission grants marketing authorisation, Pebrilzo is not authorised for use in the European Union.