Generics & Biosimilars
US biosimilars surged in 2025 with first-time rivals to Stelara, Prolia/Xgeva and Soliris, yet a growing “biosimilar void” highlights gaps in development. New FDA streamlining aims to cut costs and widen competition.
Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
In a busy year for US biosimilars, 2025 saw more than a dozen approvals as multiple biologics faced competition for the first time – including Stelara. However, concerns persist over the lack of rivals in development for numerous brands coming off-patent, with a hope that regulatory streamlining can