Fresenius Kabi Submits Its First Biosimilar Marketing Authorization Application To European Medicines Agency For MSB11022, A Biosimilar Of Adalimumab

Fresenius Kabi is publishing recently that its first Marketing Authorization Application (MAA) has been submitted and been accepted for review by the European Medicines Agency (EMA) for MSB11022, a biosimilar candidate of Humira (adalimumab). The application includes the results of the Phase III AURIELPsoriasis (PsO) study showing equivalent efficacy of MSB11022 to the originator Humira.

This submission represents Fresenius Kabi's first biosimilar candidate submitted in the European Union. In 2017, Fresenius Kabi acquired the biosimilars business of Merck KGaA which comprises the entire development pipeline that has a focus on oncology and autoimmune diseases. Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceutials Division, said: “With our future biosimilars products, we will help fill a vital need in health care. Patients, healthcare professionals and payers may benefit from access to a greater choice of state-of-the-art and affordable therapies.”

“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,” said Michael Soldan, Head of the Business Unit Biosimilars, Pharmaceutials Division, Fresenius Kabi. “This is an important step in the development of our entire biosimilar pipeline.”

Fresenius Kabi’s MAA submission includes analytical, pharmacokinetic, efficacy, safety and immunogenicity data. The Phase III study in moderate-to-severe plaque psoriasis met its primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of MSB11022 were also comparable to adalimumab in the clinical studies. Data to support the transition of adalimumab patients to MSB11022 are included in the MAA.

About MSB11022, a proposed biosimilar of Humira (adalimumab) MSB11022 is being developed as a biosimilar of adalimumab by Fresenius Kabi SwissBioSim using advanced analytical methods. Adalimumab is a biologic therapy approved in the EU for use in the treatment of several chronic conditions including plaque psoriasis, Crohn's disease, ulcerative colitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, hidradenitis suppurativa and ankylosing spondylitis.

About Fresenius Kabi

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for collection and processing of blood components and for therapeutic treatment of patient blood by apheresis systems. In the field of biosimilars, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases. With its corporate philosophy of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs over 35,000 people worldwide. In 2016 the company reported sales of about €6B. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA health care group.

For more information, visit www.fresenius-kabi.com.