Bio-Thera Solutions' BAT2206, Stelara® Biosimilar, Accepted for Regulatory Review in US and EU

GUANGZHOU, China, July 24, 2024 -- Bio-Thera Solutions Inc., a biopharmaceutical company engaged in developing a range of innovative therapies and biosimilars, announced that the FDA has accepted their BLA for BAT2206, an interchangeable biosimilar to Stelara® (ustekinumab), for a commercial license in the United States. Similarly, the EMA has accepted their MAA for BAT2206 seeking a commercial license in the EU. The China National Medicinal Product Administration (NMPA) is also reviewing a Biologics License Application for BAT2206.

Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions, emphasized the significance of FDA and EMA accepting the BLA and MAA for BAT2206. He highlighted that this is the first ustekinumab biosimilar developed by a Chinese company to be submitted for approval in these regions. Dr. Li reiterated Bio-Thera's dedication to providing affordable therapeutic options globally by developing BAT2206.

The BLA/MAA for BAT2206 is based on extensive evidence from analytical, non-clinical, and clinical studies. Detailed analytical characterization of the structural, physicochemical, and biological properties of BAT2206 has been carried out, demonstrating its biosimilarity to the reference product. A randomized double-blind, single-dose, three-arm, parallel group Phase 1 study evaluated the pharmacokinetics, safety, and immunogenicity of BAT2206 compared to both the EU and US reference ustekinumab in healthy volunteers. Additionally, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study assessed BAT2206 versus ustekinumab for equivalent efficacy, and comparable pharmacokinetic, safety, and immunogenicity profiles, in subjects with Moderate to Severe Plaque Psoriasis.

BAT2206 is proposed as a biosimilar to Stelara®, a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by blocking shared p40 from binding to the IL-12Rβ1 receptor protein on immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, including natural killer cell activation and CD4+ T-cell differentiation and activation. These cytokines are considered significant contributors to chronic inflammation in diseases like Crohn's disease and ulcerative colitis, among other autoimmune conditions. In the U.S., Stelara® is approved for treating adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. Stelara® is also approved for treating pediatric patients (6 years and older) with moderate to severe plaque psoriasis and active psoriatic arthritis.

Bio-Thera Solutions, Ltd., based in Guangzhou, China, is a global biopharmaceutical company focused on researching and developing novel therapeutics for cancer, autoimmune, cardiovascular, and eye diseases, as well as biosimilars for existing branded biologics. The company has three approved products: QLETLI® in China, TOFIDENCE™/BAT1806 in the US, EU, and China, and Avzivi®/Pobevcy® in the US and China. Bio-Thera has over 20 promising candidates in clinical trials, with a focus on immuno-oncology and targeted therapies such as antibody-drug conjugates (ADCs).

This development underscores Bio-Thera’s commitment to aiding patients worldwide by providing cost-effective therapeutic solutions.

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