Shares of Biocon, Zydus Lifesciences, and Aurobindo Pharma moved higher by up to 2% after the companies announced regulatory milestones achieved in the US and European Union markets.

Zydus Lifesciences reported the successful completion of a surveillance inspection by the US Food and Drug Administration (USFDA) at its API manufacturing facility in Dabhasa, Gujarat. The inspection, which took place between 21 April and 25 April, resulted in six observations. Importantly, the company noted that none were related to data integrity issues and expressed confidence in addressing the findings promptly.

Meanwhile, Biocon Biologics, a subsidiary of Biocon, received positive recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its biosimilars, Vevzuo and Denosumab BBL, both designed for bone-related conditions. These recommendations will now move to the European Commission for final marketing approvals.

Similarly, Aurobindo Pharma’s biologics division, CuraTeQ Biologics, secured a CHMP-positive opinion for its trastuzumab biosimilar, Dazublys, targeted at treating HER2-positive breast cancer. The company anticipates receiving full EU approval by July 2025. This development marks the third CHMP positive opinion Aurobindo has received for a biosimilar within just five months, supporting its ambition to introduce 10 biosimilars by 2030.

At around 13:30 pm, shares of Zydus Lifesciences closed 2.95% higher at Rs 885.05 on NSE. Biocon shares closed 2.90% higher at Rs 320.90, while Aurobindo Pharma shares closed 2.45% higher at Rs 1,250 on NSE. 

Tired of missing hot stocks? Unicorn Signals provides powerful tools like stock scans and more help you make informed trading decisions. Download now and take control of your portfolio!