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Eye on Pharma: JHL Biotech to Begin Phase 3 Trial of Biosimilar Trastuzumab
This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.
This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.
The potential biosimilar will be referenced on Herceptin, a monoclonal antibody approved for the treatment of HER2-positive breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma.
Click here to see a full list of US- and EU-approved trastuzumab biosimilars.
In the positive scientific advice sent by the EMA, the regulator agreed with the development approach of the potential biosimilar as well as the phase 3 clinical study design and the clinical development proposal. Assuming the trial is completed successfully, the results will be acceptable for submission of a Marketing Authorization Application.
This is just the latest update in clinical trials underway by JHL, as last month it announced that it had received positive scientific advice from the EMA's CHMP in regard to its potential rituximab biosimilar, JHL1101. Additionally, JHL also received a Clinical Trial Permit from the Center for Drug Evaluation of the State Drug Administration of China to initiate the same global phase 3 study of JHL1101. JHL plans to launch the trial in China, Europe, and other countries in the coming months.
The market for trastuzumab biosimilars is becoming more competitive, with 4 biosimilar products—Ontruzant, Herzuma, Kanjinti, and Trazimera—licensed in the European Union, and 1-Ogivri—licensed in the United States.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
