The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

A biopharma conference in Mumbai hears how the US biosimilars landscape could potentially change over the long term when deep price cuts set in and payers have a greater say in matters. Might big pharma consider pulling out?

Against a backdrop of US FDA warnings and global regulatory convergence, the Indian pharma industry is looking to build in quality from project inception and foster an unbiased approach to quality across global markets, a conference in Mumbai hears.

Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.