Aurobindo Pharma Limited (along with its subsidiaries together referred to as “Aurobindo”) announced that the breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its wholly owned subsidiary company, Curateq Biologics Private Limited, has met its primary endpoint in Phase 3 clinical trial (Trial No.: CR201-18), the company on Tuesday announced through an exchange filing.
BP02 has shown equivalent efficacy to Herceptin® in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile.
About Phase 3 study
The phase 3 study is a multi-centre, randomized, double-blinded study involving females with metastatic HER2- positive breast cancer. The trial was carried out to demonstrate product equivalence in terms of efficacy vis-àvis EU sourced Herceptin®. Additionally, the trial also compared pharmacokinetics, safety, and immunogenicity of BP02 vs originators product. The trial enrolled a total of 690 patients, who were randomly assigned in a 1:1 ratio to one of the two parallel treatment groups. They received concomitant chemotherapy (docetaxel). The overall response rate fell well within both the FDA risk ratio-based equivalency margin (0.80 - 1.25) and the EMA risk difference-based equivalency margin (-13, +13). The results demonstrated that BP02 met equivalence to Herceptin® in terms of clinical response and the safety profiles of the two treatment arms were shown to be comparable during the treatment phase.
Earlier, CuraTeQ completed a randomized, double-blind, parallel three arm Phase 1 study (BP02-101) in healthy volunteers with BP02 and Herceptin® sourced from the US and EU. The study included 111 healthy volunteers who were administered a single dose of BP02 or EU-Herceptin® or US-Herceptin® in a 1:1:1 ratio. The results demonstrated similar bioavailability (point estimate of 1.0) and all the pharmacokinetic parameters were within the equivalency margin of 0.80 -1.25. BP02 was proven to be bioequivalent to Herceptin® sourced from the US and EU.
“We are excited by this study outcome. CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter. We hope to complete market authorization (MA) application submissions across all key regulated markets in a phased manner, by March 2024. Our first submission will be in India in July 2023,” said Dr.Satakarni Makkapati, CEO, Biosimilars, Vaccines and Peptide.
About the company
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.