JHL Biotech Cleared for Phase 1 Clinical Trial of Proposed Bevacizumab Biosimilar

On Thursday, JHL Biotech, a biopharmaceutical startup based in Taiwan, announced that the Bulgarian Drug Agency has approved a phase 1 clinical trial application of a proposed bevacizumab biosimilar, JHL1149.

Bevacizumab (Avastin), an anti—vascular endothelial growth factor (anti-VEGF) therapy, is commonly used to treat metastatic colorectal cancer, lung cancer, and ovarian cancer, and is frequently used off-label to treat eye diseases. According to JHL, bevacizumab generated worldwide revenues of approximately $7 billion in 2016.

The phase 1 study will be a 3-arm pharmacokinetic study in healthy volunteers in Bulgaria, and is set to begin next month. The data derived from this study will support the development and eventual commercialization of JHL1149.

The first US-authorized bevacizumab biosimilar, Mvasi, was approved by the FDA in December 2017, and received the European Commission’s (EC) marketing authorization last month, though no official launch date has been announced in either territory.

In addition to bevacizumab, JHL is working on a number of other biosimilars including rituximab (Rituxan), trastuzumab (Herceptin), and dornase alfa (Pulmozyme).

JHL’s proposed rituximab biosimilar, currently in phase 1 trials in the European Union (EU), would potentially treat lymphoma, leukemia, and rheumatoid arthritis. The trastuzumab biosimilar, to treat HER2-positive breast cancer, is currently in the process of filing phase 1-related paperwork.

In December 2017, JHL announced the submission of a phase 1 trial application to the Dutch Healthcare Authority for the proposed dornase alfa biosimilar, JHL1922, which is intended to improve pulmonary function in cystic fibrosis patients. The trial is scheduled to begin in the Netherlands next month.