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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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
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.
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.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
