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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.
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
