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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).
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April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
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