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JHL Biotech to Begin Phase 3 Trial of Biosimilar Rituximab Candidate
This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.
This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted the company positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.
“The EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global phase 3 clinical study for JHL1101 in patients with diffuse large B-cell lymphoma,” read the release.
After the EMA had reviewed each of these factors in accordance with the existing approval pathway for biosimilars in the European Union (EU), CHMP has deemed that the results of the phase 3 trial will be acceptable for the submission of a marketing authorization application, assuming the study finds positive results.
In addition, JHL Biotech 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 study in China, Europe, and other countries in the coming months.
“This study adds to the data collected in the JHL1101 EU study and will differentiate JHL from many of its competitors. JHL Biotech is one of the few companies conducting clinical trials with biosimilars globally,” said Racho Jordanov, CEO and co-chairman of JHL in a prepared statement.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
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.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
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.
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.
