Celltrion has shared promising phase 3 results of its biosimilar candidate referencing Roche’s RoActemra (tocilizumab) in patients with moderate-to-severe rheumatoid arthritis (RA).
Results from the comparative study, which evaluated the candidate CT-P47 compared to RoActemtra in 471 patients with moderate-to-severe RA, were presented at the 2024 Annual European Congress of Rheumatology.
Affecting approximately 1% of the population worldwide, RA is a chronic inflammatory disease that causes pain, swelling and stiffness in joints.
Containing the active ingredient tocilizumab, CT-P47 is a recombinant humanised monoclonal antibody that acts as an interleukin 6 receptor antagonist.
Biosimilars are biological medicines that are highly similar to ones already approved, have the same safety and efficacy as the reference product, and are less costly for healthcare systems.
For the first 20 weeks, patients either received either CT-P47 or RoActemra every four weeks at a dose of 8mg. After 24 weeks, patients receiving RoActemra were re-randomised to either continue with the treatment or undergo transition to CT-P47.
Results showed that the investigational CT-P47 was highly similar in terms of efficacy and comparable safety and immunogenicity profile to RoActemra for the treatment of RA up to 32 weeks.
In addition, a phase 1/2 study comparing pharmacokinetic similarity between the CT-P47 autoinjector and the pre-filled syringe showed higher usability of the CT-P47 autoinjector compared to the pre-filled syringe in RA patients, with no new safety signals identified.
Taehun Ha, vice president and head of Europe division, Celltrion, commented: “We believe that administration of CT-P47 via an autoinjector presents an alternative delivery option to a pre-filled syringe in clinical practice and aims to improve treatment compliance.”
Dr Josef Smolen, Emeritus professor of medicine, Medical University of Vienna, Austria, said: “The positive… results from the phase 3 study support the biosimilarity of CT-P47 to reference tocilizumab and also provide clinical evidence for the possibility of switching from reference tocilizumab to CT-P47.”
The biopharmaceutical company filed CT-P47 for regulatory approval with the US Food and Drug Administration and the European Medicines Agency in January and February 2024, respectively.
In May, the European Commission approved Celltrion’s Omlyclo (CT-P39), a biosimilar referencing Novartis and Genetech’s Xolair (omalizumab), for a range of immunological conditions.