Earlier this week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided it with positive scientific advice regarding JHL1101, its proposed biosimilar of MabThera® (rituximab). According to the press release, “the EMA confirmed that it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1101 in patients with diffuse large B-cell lymphoma,” which will make the study results “acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully.” JHL further stated that, “[p]rovided the proposed studies provide sufficient evidence, an extrapolation for all approved indications of MabThera … can be considered.” The press release also noted that JHL recently received a Clinical Trial Permit (CTP) from the Center for Drug Evaluation (CDE) of the State Drug Administration of China (SDA), which will allow JHL to initiate a global Phase III study of JHL1101 in patients with diffuse large B-cell lymphoma in China, Europe, and other countries in the following months.
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