Biopharmaceutical startup JHL Biotech Inc reported on Thursday the receipt of approval from the European authority, Bulgarian Drug Agency for a Phase I Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149.
Following the approval, the company will launch a three-arm pharmacokinetic study in healthy volunteers in Bulgaria beginning March 2018.
The company said that the data from this trial will support the rapid development and commercialisation of JHL1149. JHL1149 would provide an affordable alternative to bevacizumab, a biologic used to treat many cancers, the most common of which are metastatic colorectal cancer, lung cancer and ovarian cancer.
Currently, the company expects several biosimilars to be in clinical trials: Rituximab biosimilar (JHL1101) to treat rheumatoid arthritis and Non-Hodgkin's Lymphoma; Dornase alfa biosimilar (JHL1922) to manage symptoms of cystic fibrosis; as well as Trastuzumab biosimilar (JHL1188) to treat breast cancer.
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