JHL Biotech Inc. announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency has authorized the company to begin a clinical trial for JHL1101, a biosimilar to rituximab, for patients with rheumatoid arthritis, according to a company press release.
The randomized, double-blind phase 1 trial is expected to begin later this year and will evaluate the safety and efficacy, as well as the pharmacokinetic and pharmacodynamic similarity, of JHL1101 to rituximab (MabThera, Roche). About 150 patients with severe rheumatoid arthritis (RA) are expected to enroll in the trial in locations in Europe.
The biosimilar employs the same drug delivery method as the reference product, hence it is exempt from phase 2 trials in the United Kingdom and can move directly to phase 3 following a successful phase 1 trial demonstrating similarity to the reference product, according to the release.
“JHL is the first company from Greater China to receive European approval to conduct [a] biosimilar clinical trial, which speaks to the quality of our team and commitment of our people,” Racho Jordanov, the chief executive officer of JHL, said in the release. “Countless international pharmaceutical companies have attempted to develop a rituximab biosimilar. Rituximab has a complex structure, and JHL had to develop a product identical in quality, safety, and efficacy to its Roche reference. We are proud to have produced this product and advance it into clinical development.” – by Shirley Pulawski