On 8 January 2026, the Munich Regional Court granted Regeneron and Bayer preliminary injunctions (PIs) preventing STADA, Hexal, Celltrion and Advanz Pharma from marketing their aflibercept biosimilars in Germany and requiring them to recall any products already on the market. According to a Juve Patent report, while the PI against STADA, Hexal and Celltrion is limited to Germany, the PI against Advanz covers 21 countries.
The Court’s rulings are based on Regeneron’s patent, EP 2 364 691, relating to a formulation of aflibercept, the active ingredient of Regeneron/Bayer’s Eylea®.
The biosimilars restrained by the PIs granted by the Court are as follows:
- Afqlir®, a product of the Sandoz Group, of which Hexal is a part in Germany. 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;
- Celltrion’s Eydenzelt® (CT-P42), which received European approval in February 2025;
- Advanz’s Mynzepli®, which was approved in Europe in August 2025. Mynzepli® (AVT06) was developed by Alvotech and, under a June 2024 agreement, Advanz has the exclusive commercialisation rights to the product throughout Europe, except in Germany and France, where the rights are semi-exclusive; and
- STADA’s Afiveg®, which was EU approved in September 2025.
Celltrion has subsequently announced that it is “actively pursuing patent agreements” with Regeneron/Bayer in relation to aflibercept, including in Germany, in order to “quickly introduce the product to the market”.
The successful PI applications by Regeneron/Bayer in Germany follow a PI granted by the same German court in September 2025, with a permanent cross-border injunction granted in October 2025, preventing Formycon from launching its aflibercept biosimilar, FBY203 (Baiama®/Ahzantive®), in multiple European countries. Formycon has lodged an appeal.
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.