Regeneron and Bayer have withdrawn a preliminary injunction (PI) application against Sandoz in Germany in relation to Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg). According to a JUVE Patent report of 27 March 2026, the result is that Sandoz and its German subsidiary, Hexal, are now free to market Afqlir® in Germany.
The withdrawal of the PI application follows a February 2026 decision of the Munich Higher Regional Court to provisionally suspend enforcement of a first instance judgment. That first instance judgment, issued in January 2026, had granted Regeneron and Bayer a preliminary injunction preventing Hexal/Sandoz from marketing their aflibercept biosimilar in Germany. In a March 2026 interim order, the Court also cited the lack of any urgency in relation to the PI.
Sandoz’s Afqlir® was EU-approved in November 2024 and was launched in the UK in November 2025. At the time of the UK launch, Sandoz announced that launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026.
German Courts have issued PIs in relation to a number of aflibercept biosimilars. At the same time as granting the PI against Sandoz in January 2026, the Munich Regional Court granted PIs against STADA, Celltrion and Advanz Pharma. While the PIs against STADA, Hexal/Sandoz and Celltrion were limited to Germany, the PI against Advanz covered 21 countries. A PI (September 2025), and subsequent permanent cross-border injunction (October 2025) were also granted preventing Formycon from launching its aflibercept biosimilar, FBY203 (Baiama®/Ahzantive®), in multiple European countries.
Since that time a number of EU settlements have been reached in relation to aflibercept biosimilars. Samsung Bioepis reached a settlement and licence with Regeneron/Bayer in January 2026, permitting it to launch SB15 (Opuviz®) in the UK from January 2026 and in the EU from April 2026. Alvotech’s commercialisation partners, Advanz Pharma (EU/UK) and STADA (Germany) are also permitted to launch AVT06/Mynzepli®/Afiveg® (aflibercept) in the EU from May 2026, following a settlement announced in January 2026. In March 2026, Formycon and Klinge announced they had entered a settlement agreement with Regeneron/Bayer permitting launch of their aflibercept biosimilar, FYB203 (Baiama®/Ahzantive®), in Europe, and key regions in APAC and LATAM from May 2026. According to Celltrion, it is “actively pursuing patent agreements” with Regeneron/Bayer in relation to aflibercept, including in Germany.
In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Mynzepli® (AVT06) (aflibercept). This ruling cleared the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1 183 353 (encompassing aflibercept) on 23 November 2025.