Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid arthritis in the Annals of the Rheumatic Diseases. The researchers reported that in the phase I trial CT-P10 and rituximab “demonstrated equivalent pharmacokinetic and comparable efficacy, pharmacodynamics, immunogenicity and safety.”
Rituximab is an anti-CD20 monoclonal antibody that is approved under the brand Rituxan® for treating a variety of cancers and inflammatory conditions, including for rheumatoid arthritis when combined with methotrexate. Earlier this month, we reported that Teva and Celltrion had announced an exclusive partnership to commercialize CT-P10. Celltrion has filed petitions for IPR of Genentech’s and Biogen’s rituximab-related patents.
Stay tuned to the Big Molecule Watch for further developments.