- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
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.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
