Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456 shows positive results in two clinical trials

Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announced today that its tocilizumab biosimilar candidate MSB11456 successfully met its primary and secondary endpoints in two consecutively conducted clinical trials. The two Phase 1 studies used respectively subcutaneous and intravenous formulations to capture the two different routes of administration to evaluate the tocilizumab biosimilar candidate’s bioequivalence, safety and immunogenicity, in comparison to its reference candidates.

The first Phase 1 study, a randomized, double-blind, parallel-group study to determine the pharmacokinetic, pharmacodynamic, safety, tolerability and immunogenicity of MSB11456 following a single subcutaneous injection in healthy subjects, met all primary and secondary endpoints. Pharmacokinetic equivalence of MSB11456 to both the US reference product* and the EU reference medicinal product** was successfully demonstrated. The clinical trial also confirmed the similarity of MSB11456 and the US reference product* and the EU reference medicinal product** at pharmacodynamic​ level and no noteworthy differences in safety and immunogenicity were observed across the three treatment groups (MSB11456, US reference product* and EU reference medicinal product**).

The second, more recent Phase 1 study was also a randomized, double-blind, parallel-group study to evaluate the pharmacokinetic, safety, immunogenicity and tolerability of MSB11456 versus its US reference product* after a single intravenous infusion in healthy volunteers. This clinical trial met all primary and secondary endpoints. Pharmacokinetic equivalence of MSB11456 and US reference product* was successfully demonstrated and no noteworthy differences in safety and immunogenicity were observed across the two treatment groups (MSB11456 and US reference product*).

“The successful outcomes of both studies represent an important milestone in our commitment to provide high-quality and affordable biosimilar products to more healthcare providers and patients around the world. We continue to expand our biosimilar portfolio to provide affordable alternative solutions for people living with autoimmune diseases,” said Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President Pharmaceuticals and Devices Division.

The company has also initiated a global Phase 3 study with the aim to compare the efficacy, safety, tolerability and immunogenicity of its tocilizumab biosimilar candidate MSB11456 with the EU reference product in patients with moderately to severely active rheumatoid arthritis. The enrollment of patients from several countries across Europe has been completed.

Further study details can be found on: www.clinicaltrials.gov

^{* US Reference product Actemra®. 
** EU Reference product RoActemra®. 
Actemra® and RoActemra®  are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.}

For more information about Fresenius Kabi’s work in biosimilars, please visit www.biosimilars.fresenius-kabi.com

---

Fresenius Kabi is a global healthcare 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 devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

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 around 40,500 people worldwide. In 2020, the company reported sales of more than €7.0 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information, please visit w​ww.fresenius-kabi.com

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

^{Fresenius SE & Co. KGaA 
Registered Office: Bad Homburg, Germany 
Commercial Register: Amtsgericht Bad Homburg, HRB 11852 
Chairman of the Supervisory Board: Wolfgang Kirsch} 

^{​General Partner: Fresenius Management SE 
Registered Office: Bad Homburg, Germany 
Commercial Register: Amtsgericht Bad Homburg, HRB 11673 
Management Board: Stephan Sturm (Chairman), Dr. Sebastian Biedenkopf, Dr. Francesco De Meo, Rachel Empey, Rice Powell, Michael Sen, Dr. Ernst Wastler 
Chairman of the Supervisory Board: Wolfgang Kirsch}