- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
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?
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
