At a Glance
- Companies: ADVANZ PHARMA; Alvotech; Bayer; Regeneron
- Location: UK; EEA; Switzerland
- Headline figures: Patent settlement (terms confidential)
- Focus area: Eylea® 2mg (aflibercept 40 mg/mL) biosimilar
- Next steps: UK launch 1 Jan 2026; EEA/Switzerland 1 May 2026
What happened?
ADVANZ PHARMA and partner Alvotech reached a global licensing and settlement agreement with Regeneron and Bayer on 30 January 2026, resolving all remaining worldwide patent disputes for Alvotech’s Eylea® 2mg biosimilar (aflibercept). The deal clears the path for UK launch on 1 January 2026 and EEA/Switzerland from 1 May 2026 (other terms confidential).
Why does it matter?
Eylea generates ~US$12bn annually for retinal diseases; biosimilar entry could improve access and affordability amid growing demand for anti-VEGF therapies. Settlement provides regulatory certainty for commercialisation in Europe, complementing prior US Q4 2026 agreement.
Who’s behind it?
ADVANZ PHARMA (UK focus on specialty/hospital medicines) partners with Alvotech (biosimilars developer); biosimilar approved as Mynzepli® (UK/EEA), Afiveg® (EEA), Aflibercept BS (Japan).
How was it achieved?
Confidential licensing resolves litigation; builds on EMA/MHRA/MHLW approvals and prior US settlement, enabling Alvotech to supply global partners.
What’s next?
ADVANZ prepares UK commercialisation; EEA rollout May 2026; US pending FDA approval Q4 2026; Japan May/Nov 2026.
What are people saying?
Alvotech CEO Robert Wess: “Robust regional commercial partners… exceptionally well-prepared for successful introduction.” ADVANZ: “Defined pathway for future commercialisation.”