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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.
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Escaping the Void: All Things Biosimilars With Craig & G
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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?
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
