Eye on Pharma: JHL Biotech to Begin Phase 3 Trial of Biosimilar Trastuzumab

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.

The potential biosimilar will be referenced on Herceptin, a monoclonal antibody approved for the treatment of HER2-positive breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma.

Click here to see a full list of US- and EU-approved trastuzumab biosimilars.

In the positive scientific advice sent by the EMA, the regulator agreed with the development approach of the potential biosimilar as well as the phase 3 clinical study design and the clinical development proposal. Assuming the trial is completed successfully, the results will be acceptable for submission of a Marketing Authorization Application.

This is just the latest update in clinical trials underway by JHL, as last month it announced that it had received positive scientific advice from the EMA's CHMP in regard to its potential rituximab biosimilar, JHL1101. Additionally, JHL also received a Clinical Trial Permit from the Center for Drug Evaluation of the State Drug Administration of China to initiate the same global phase 3 study of JHL1101. JHL plans to launch the trial in China, Europe, and other countries in the coming months.

The market for trastuzumab biosimilars is becoming more competitive, with 4 biosimilar products—Ontruzant, Herzuma, Kanjinti, and Trazimera—licensed in the European Union, and 1-Ogivri—licensed in the United States.