Fresenius Kabi Submits Adalimumab Biosimilar Marketing Application to EMA

Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA). Adalimumab is a biologic therapy approved in the European Union and elsewhere for the treatment of multiple inflammatory diseases.

“MSB11022 was developed as a therapeutic solution for patients with chronic inflammatory diseases and has the potential to play an impactful role in long-term disease management. This is an important step in the development of our entire biosimilar pipeline,” said Michael Soldan, head of the business unit biosimilars, pharmaceuticals division for Fresenius Kabi, in a statement.

Fresenius Kabi’s submission concerning MSB11022 includes analytical, pharmacokinetic, efficacy, safety, and immunogenicity data. The phase 3 study, AURIEL-Psoriasis, met its primary endpoint of demonstrating clinical equivalence to the reference adalimumab. The safety and immunogenicity of MSB11022 were also comparable to adalimumab in the clinical studies, and the data to support the transition of adalimumab patients to MSB11022 was included in the application.

MSB11022 is Fresenius Kabi’s first biosimilar candidate submitted to the EMA. In September 2017, Fresenius Kabi acquired the biosimilar business of Merck KGaA, which included the latter company’s entire development pipeline that maintains a focus on oncology and autoimmune diseases.

The potential approval of MSB11022 would add to the ranks of other adalimumab biosimilars approved in the EU for the reference product, Humira. In September 2017, Amgen announced that it had reached a settlement with AbbVie, developer of Humira, over Amgen’s biosimilar adalimumab, Amgevita. The settlement cleared the way for Amgen to launch its biosimilar in the European Union in October 2018. (In the United States, the biosimilar, which will be marketed under a slightly different name, Amjevita, is cleared to launch in January 2023.)

In addition, Cyltezo, Boehringer Ingelheim’s adalimumab biosimilar, was granted a marketing authorization by the European Commission in November 2017, and Samsung Bioepis’ adalimumab biosimilar, Imraldi, was approved in the European Union in August 2017.