JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Rituximab Biosimilar.
JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed rituximab biosimilar, JHL1101, Tuesday (7/10).
The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed 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.
Based on the EMA's review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully. Provided the proposed studies provide sufficient evidence, an extrapolation for all approved indications of MabThera (a brand name of rituximab) can be considered.
JHL has also recently received a Clinical Trial Permit (CTP) from the Center for Drug Evaluation (CDE) of the SDA for a global Phase III clinical study of JHL1101 in patients with diffuse large B-cell lymphoma. Therefore, a global Phase III study of JHL1101 can be initiated in China, Europe, and other countries in the following months.
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|Publication:||The President Post (Jakarta, Indonesia)|
|Date:||Jul 31, 2018|
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