Biocon Biologics completes Integration of Viatris' Biosimilar business
The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone
The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone
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 recently acquired the global biosimilars business of its long-term partner Viatris
Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
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