Warning notes may precede or follow import alerts, US FDA clarifies

Do US FDA’s efforts at simplifying the biosimilar pathway create more competition and threaten Aurobindo Pharma's return on investments? Management speaks on this, biosimilar filing plans and deal strategy at the Q2 FY26 earnings call

Cipla’s global CEO and MD Umang Vohra is moving on handing over the baton to global COO, Achin Gupta. Vohra talks about his innings, where he sees Cipla in 2030 and the impact of the latest FDA action that aims to make biosimilar development faster and less costly.

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.