The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.

Shreehas Tambe has been named as CEO of Biocon Biologics, taking over from Arun Chandavarkar, in the wake of the company’s milestone $3bn transaction for Viatris’s biosimilars business.

Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.

South Korea's breakthrough therapy system, Global Innovative Products Fast Track, kicks off with Roche’s follicular lymphoma drug becoming the first to test the new system. Meanwhile, a state-run group is linking with pharma firms to rapidly bring in global new drugs.