JHL Biotech receives approval from MHRA to begin biosimilar clinical trial

February 15, 2016 11:21 AM


JHL Biotech, Inc. announced it has received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trial for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis.

JHL is the first company from the Greater China region to receive European approval for clinical trial of a monoclonal antibody biosimilar.

The randomized, double-blind, multinational Phase I trial will establish similarity of JHL1101 with its reference product, Roche’s MabThera. JHL seeks to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity to MabThera as well as the safety and efficacy of JH1101. Approximately 150 patients with severe rheumatoid arthritis will participate in locations throughout Europe. Enrollment of patients into the study is expected to begin in 2016.

As a biosimilar with the same delivery mechanism and dosing as MabThera, JHL1101 is exempt from Phase II trial requirements and is eligible to undergo Phase III trial when the Phase I trial is concluded and similarity with the reference product is further validated. MabThera is the brand name for rituximab in most of the world, except for the United States, Canada, and Japan where it is administered under the name Rituxan. Rituximab is one of the most commonly used monoclonal antibody treatments for rheumatoid arthritis.

JHL Chief Executive Officer Racho Jordanov said, “JHL is the first company from Greater China to receive European approval to conduct biosimilar clinical trial, which speaks to the quality of our team and commitment of our people. 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. We currently have four other therapies in development, and this event marks the beginning of an exciting new stage in JHL’s growth.”

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