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Bio-Thera Begins Phase 1 Trial for Ustekinumab Biosimilar


Bio-Thera said it has begun testing the safety its ustekinumab biosimilar in healthy volunteers.

Guangzhou, China-based Bio-Thera Solutions has begun a phase 1 clinical trial for its proposed ustekinumab biosimilar (BAT2206), referencing Janssen’s Stelara, which is used in the treatment of plaque psoriasis and psoriatic arthritis.

The randomized, double-blind, parallel group, single-dose study will compare the pharmacokinetics and safety profiles of the biosimilar candidate to the reference product sourced from the United States and the European Union. The study will be conducted with 270 healthy volunteers.

Ustekinumab is an immunosuppressive agent delivered via injection. “BAT2206 is the fifth biosimilar that Bio-Thera has advanced into clinical development. It signifies Bio-Thera’s continued commitment to developing and providing safe, effective, and affordable biological products for patients in China and around the world,” said Shengfeng Li, PhD, CEO of Bio-Thera Solutions, in a statement.

China's National Medical Products Administration (NMPA) gave Bio-Thera clearance to start a phase 1 trial for BAT2206 in December.

Bio-Thera’s Other Biosimilars

Bio-Thera is developing a sizeable portfolio of biosimilar candidates and has a biosimilar on the Chinese market, Qletli, an adalimumab referencing Humira. Qleti launched in China in January 2020 for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.

In late August, Bio-Thera reached a tentative agreement with Beijing, China-based BeiGene to commercialize a bevacizumab biosimilar (BAT1706) for the Chinese market assuming that it receives approvald from the NMPA, which accepted Bio-Thera’s application for BAT1706 approval in June 2020.

In February, Bio-Thera announced positive results from a phase 3 clinical trial comparing the safety and efficacy of BAT1706 with its reference product, Genentech’s Avastin. Bevacizumab is used for the treatment of colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancers as well as age-related macular degeneration.

In August 2019, Bio-Thera began conducting a phase 1 study for its golimumab biosimilar (BAT2506) candidate referencing Janssen’s Simponi. Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

In July 2020, Bio-Thera signed a marketing agreement with Pharmapark to commercialize BAT2506 for Russia and other Commonwealth of Independent States (CIS) countries.

In January 2019, Bio-Thera began a phase 3 trial for its proposed tocilizumab biosimilar (BAT1806) referencing Genentech’s Actemra. Tocilizumab is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The company is also working to develop a biosimilar to Cosentyx (secukinumab), which is used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.

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