Pebrilzo (pertuzumab biosimilar) / Biocon - LARVOL DELTA

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pebrilzo, intended for the treatment of breast cancer. (European Medicines Agency) - "Pebrilzo will be available as 420 mg concentrate for solution for infusion."

CHMP • Breast Cancer

Biocon announced the signing of partnership agreement with Bahiafarma and Bionovis for Pertuzumab in Brazil, marking an important milestone in advancing production and commercialisation of the HER2-positive breast cancer therapy under the country's Productive Development Partnership (PDP) program. (Business Standard) - "The consortium of Biocon, Bahiafarma and Bionovis received 100% allocation under Brazil's 10-year PDP program for Pertuzumab....As part of the PDP framework, the product will undergo phased localization in Brazil in the mid to long term."

Licensing / partnership • HER2 Positive Breast Cancer

Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=55 | Terminated | Sponsor: Biocon Biologics UK Ltd | N=382 ➔ 55 | Trial completion date: Nov 2026 ➔ Dec 2025 | Recruiting ➔ Terminated; US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.

Enrollment change • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=382 | Recruiting | Sponsor: Biocon Biologics UK Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A randomized, double-blind, three-arm, parallel group, phase 1 study to assess the pharmacokinetics, safety, and tolerability of PERT-IJS following a single dose of 420 mg intravenous infusion compared to the EU- and US-marketed drug product (pertuzumab; PERT) in healthy male volunteers. (ASCO 2025) - "This study demonstrated PK bioequivalence as well as comparable safety, tolerability, and immunogenicity between PERT-IJS versus EU-PERT/US-PERT and EU-PERT versus US-PERT in healthy male subjects. Statistical results of pertuzumab pharmacokinetics parameters"

Clinical • P1 data • PK/PD data • Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=382 | Not yet recruiting | Sponsor: Biocon Biologics UK Ltd | Initiation date: Mar 2024 ➔ Sep 2024

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=382 | Not yet recruiting | Sponsor: Biocon Biologics UK Ltd | Initiation date: Dec 2023 ➔ Mar 2024

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Efficacy and Safety of the Proposed Biosimilar PERT-IJS Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=382 | Not yet recruiting | Sponsor: Biocon Biologics UK Ltd

Metastases • New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR