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Europe
Generics Bulletin reviews global regulatory developments across the world.
Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.
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.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
A slash in rebate rates is only a first step towards restoring the competitiveness of the UK’s pharmaceutical industry, according to the ABPI.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.
A new value set to be used by UK health technology appraisal body NICE is expected to impact the cost-effectiveness of some medicines and make room for higher drug prices.
The biopharmaceutical landscape in 2026 will be shaped by rapid technological progress, shifting geographic leadership, a looming patent cliff and a renewed focus on capital efficiency.
Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.
EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.