Biosimilars

Glancing over at the changing development requirements for biosimilars in the US and Europe, the Chinese duo Chime Biologics and Beijing Libang Pharmaceutical are allying to develop a blinatumomab biosimilar rival to Amgen’s Blincyto.

Generics Bulletin reviews global regulatory developments across the world.

Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in Brazil.

The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.

The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.

Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.

The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.

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.

Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.

The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.

The consolidation of Biocon-BBL is expected to unlock value, deliver operational synergies and provides BBL’s minority shareholders an 'earlier liquidity event'. Investor Viatris also signals accelerated expiration of biosimilars non-compete restrictions.