JHL Biotech Inc. announced last week that it received approval from the Bulgarian Drug Agency for a Phase I clinical trial of its proposed bevacizumab (Avastin) biosimilar, JHL1149. The trial, set to begin in March 2018, will consist of a three-arm pharmacokinetic study in healthy volunteers. The data acquired from the study will aid in the development and commercialization of JHL1149.
According to the announcement, in addition to bevacizumab, JHL is currently advancing with several other biosimilars including rituximab (Rituxan), trastuzumab (Herceptin), and dornase alfa (Pulmozyme). JHL states that its rituximab biosimilar, JHL1101, and dornase alfa biosimilar, JHL1922, are currently in a Phase I trials in Europe and are expected to enter additional Phase I and III trials in Europe and China in 2018. It also states that its trastuzumab biosimilar, JHL1188, is expected to begin Phase I trials in Europe in 2018.
As we previously reported, the FDA has approved Amgen’s bevacizumab biosimilar, Mvasi. The European Commission has also granted marketing authorization for Mvasi. There is currently no official launch date for either region.