Biocon's Pebrilzo becomes first monoclonal antibody biosimilar backed by EMA CHMP under tailored development approach
核心洞察
The EMA's CHMP issued a positive opinion recommending marketing authorisation for Biocon Biologics (搜索)' Pertuzumab biosimilar Pebrilzo (搜索) in HER2-positive breast cancer (搜索).
Pebrilzo (搜索) is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's tailored clinical development approach.
Biosimilarity was established through structural and functional analytical characterisation plus comparative clinical pharmacokinetic data, with no clinically meaningful differences versus the reference biologic.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) (CHMP) has issued a positive opinion recommending marketing authorisation for Pebrilzo (搜索), Biocon Biologics (搜索)' Pertuzumab biosimilar, for the treatment of HER2-positive breast cancer (搜索) across multiple disease stages. Biocon announced the opinion on September 21, 2026.
The recommendation covers Pebrilzo (搜索) as a 420 mg concentrate solution for infusion. The marketing authorisation application was submitted by Biocon Biologics (搜索) Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.
According to Biocon, this is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's tailored clinical development approach.
Indications and combination regimens
Pebrilzo (搜索) contains Pertuzumab, a monoclonal antibody that binds to human epidermal growth factor receptor 2 (HER2 (搜索)) and inhibits the proliferation of tumour cells that overexpress HER2.
The recommended indications cover three settings. In the neoadjuvant setting, the drug is indicated in combination with Trastuzumab and chemotherapy for adult patients with HER2 (搜索)-positive locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence. In the adjuvant setting, it is indicated with Trastuzumab and chemotherapy for adult patients with HER2-positive early breast cancer at high risk of recurrence. In the metastatic setting, it is indicated with Trastuzumab and Docetaxel for adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti-HER2 therapy.
Evidence base for biosimilarity
Biocon said the biosimilar underwent extensive structural and functional analytical characterisation along with comparative clinical pharmacokinetic studies. The company stated that the data demonstrated Pebrilzo (搜索) is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety or efficacy.
The application was reviewed under the EMA's tailored clinical development approach rather than a traditional programme of extensive comparative clinical trials. Biocon said the pathway reflects greater regulatory confidence in using advanced analytical and clinical pharmacology evidence to establish biosimilarity for certain monoclonal antibodies, a shift that could reduce development timelines and costs for future assets in its pipeline of more than 20 biosimilar candidates.
Regulatory next steps
The CHMP opinion is not a final marketing approval. The European Commission will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics will be made available in all official European Union languages, and the European Public Assessment Report will be published on the EMA website in the weeks following the decision.
Until the European Commission grants marketing authorisation, Pebrilzo (搜索) is not authorised for use in the European Union.
Shreehas Tambe, chief executive officer and managing director of Biocon, said the positive CHMP opinion marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer (搜索) in Europe. He added that as the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence in advanced analytical and clinical pharmacology evidence to establish biosimilarity.
Manufacturing and portfolio context
Biocon's manufacturing facility in Malaysia recently gained approval for a second drug product line, an expansion designed to double manufacturing capacity and support commercial supplies starting in the second quarter of fiscal year 2027. The company's broader portfolio includes bAspart and bDenosumab.