Biocon's Pertuzumab Biosimilar Earns CHMP Nod Under EMA's New Tailored Pathway

Biocon Biologics announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending marketing authorization for its pertuzumab biosimilar, to be sold under the brand name Pebrilzo, as a 420 mg concentrate solution for infusion.¹ The recommendation covers treatment of HER2-positive breast cancer across multiple disease stages.¹ The European Commission will now conduct its final review before issuing a formal decision; until that decision is granted, the product is not authorized for use in the EU.¹

What is Pebrilzo indicated for?

Pebrilzo references pertuzumab, sold as Perjeta by Roche.³ The recommended indications mirror the reference product: in combination with trastuzumab and chemotherapy for neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence; in adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence; and, combined with trastuzumab and docetaxel, in HER2-positive metastatic or locally recurrent unresectable breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.¹

What makes this approval path different?

Biocon describes Pebrilzo as the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's tailored clinical development approach.¹ That framework stems from EMA's reflection paper on a tailored clinical approach in biosimilar development, adopted by CHMP on March 16, 2026, which concludes that biosimilars may be approved without a dedicated comparative efficacy study, or even pharmacodynamic data, when analytical comparability, in vitro pharmacology, and a comparative pharmacokinetic trial are sufficient to infer similar clinical efficacy and safety.² Biocon said the CHMP recommendation for Pebrilzo was based on extensive structural and functional analytical characterization together with comparative clinical pharmacokinetic data.¹

"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," said Shreehas Tambe, chief executive officer and managing director, Biocon.¹

How does this fit into the broader pertuzumab biosimilar landscape?

Pebrilzo would not be the first pertuzumab biosimilar to reach the EU market. Henlius and Organon's Poherdy secured European Commission approval in April 2026 as the first and, at the time, only approved biosimilar to Perjeta in Europe.³ Henlius described Poherdy's approval as resting on a comprehensive data package that included structural and functional analytical data, comparative clinical pharmacokinetic data, and comparative clinical studies.³ Biocon's distinction is narrower and specific to methodology: it is the first monoclonal antibody biosimilar to clear CHMP review under the newly adopted tailored pathway, which the company's release frames around analytical and pharmacokinetic evidence rather than describing a dedicated comparative efficacy trial.¹

Why does this matter for HER2-positive breast cancer patients?

Breast cancer was the most frequently diagnosed cancer type in the EU in 2022, accounting for an estimated 13.8% of all new cancer cases, and represented 29.4% of new cancer cases among women that year.⁴

What happens next?

Following a European Commission decision, the Summary of Product Characteristics will be published in all EU official languages, and the European Public Assessment Report will follow on the EMA website.¹ Biocon has commercialized 12 biosimilar products and more than 30 generic formulations globally, with a pipeline of more than 20 additional biosimilar assets.¹

References

1. Biocon. Biocon's Pertuzumab Becomes First Biosimilar to Secure EMA CHMP Approval Recommendation Under New Tailored Clinical Approach. Press release. Published September 22, 2026. Accessed September 22, 2026.
2. EMA/CHMP/BMWP/60916/2025. Reflection Paper on a Tailored Clinical Approach in Biosimilar Development. European Medicines Agency. Adopted March 16, 2026. Accessed September 2026.
3. Shanghai Henlius Biotech, Inc.; Organon. European Commission (EC) Approves Henlius and Organon's POHERDY (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe. Press release. Published April 29, 2026. Accessed September 2026.
4. European Commission, Joint Research Centre. Breast Cancer Factsheet. ECIS – European Cancer Information System. Published October 2023. Accessed September 2026.