Biosimilars

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.

Collaboration aims to bring two biosimilars for osteoporosis and osteoarthritis to Mexico, with Saya leading commercialization and Enzene overseeing development and manufacturing.

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.

While the long-awaited pembrolizumab biosimilar deal certainly boosts Formycon’s financials, it is unclear whether it will be enough to meet its annual guidance.

Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.