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Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 270 people. The study will use US-sourced and EU-sourced reference products.
Bio-Thera joins other companies seeking to develop ustekinumab biosimilars, including Formycon (which is developing FYB202) and NeuClone.
“This IND approval represents an important milestone for our biosimilar pipeline,” said Shengfeng Li, chief executive office of Bio-Thera Solutions, in a statement. “BAT2206 will be the fifth biosimilar that Bio-Thera will advance into clinical development. It signifies Bio-Thera’s continued commitment to developing and commercializing biosimilar products for patients in China and around the world.”
In the United States, ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.
Bio-Thera Solutions is developing several additional biosimilar products, including Qleti, a biosimilar to reference adalimumab (Humira) that was recently approved in China; it is also evaluating BAT1706, a bevacizumab biosimilar to Avastin, in a global phase 3 clinical trial.
Bio-Thera Solutions is also pursuing biosimilar versions of tocilizumab (Actemra), secukinumab (Cosentyx), and golimumab (Simponi).
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
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 Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
