On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi. The Fresenius patent, EP 3 145 488 B1, claims a liquid pharmaceutical composition consisting of 50 mg/mL adalimumab, a citrate buffering system, sugar stabiliser, tonicifier and surfactant in a certain molar ratio.
In overturning a 2022 decision of the Dusseldorf Regional Court, the Higher Court granted an injunction preventing Biogen’s sales of Imraldi® in Germany and ordering Biogen to recall and destroy existing inventory and to pay damages in an amount to be determined.
An opposition to the EP ‘488 patent in the European Patent Office by Samsung Bioepis and Biogen was rejected on 20 June 2024 by the Technical Board of Appeal.
Imraldi® received European regulatory approval in 2017 and was launched in Europe in October 2018 under a licence from AbbVie entered into in April 2018. It is known as Hadlima® in the US, where it is commercialised by Organon (approved July 2019, launched in July 2023).
Fresenius Kabi’s citrate-free adalimumab biosimilar, Idacio® was approved in Europe in 2019 and in the US in December 2022. It was launched in Europe in 2019 and in the US in July 2023.