Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients

Biocon Biologics completes integration of Viatris Biosimilars’ business in North America

Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris

Biocon Biologics expands footprint in emerging markets

Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China

Enhertu to demonstrate a significant survival benefit vs. chemotherapy

Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business

To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools

ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial

Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients