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 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: https://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 https://biosimilars.fresenius-kabi.com