Bio-Thera Solutions' Ustekinumab Biosimilar BAT2206 Gains Regulatory Acceptance in US and EU
核心洞察
Bio-Thera Solutions (搜索) announced FDA acceptance of the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara® (ustekinumab), seeking US commercial license.
The EMA has also accepted Bio-Thera's MAA for BAT2206, a biosimilar to Stelara®, marking the first ustekinumab biosimilar from a Chinese company submitted to both agencies.
BAT2206's BLA/MAA is supported by comprehensive analytical, non-clinical, and clinical data, demonstrating biosimilarity and equivalent efficacy to the reference product.
Bio-Thera Solutions (搜索) has achieved a significant milestone with the acceptance of its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) and its Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for BAT2206, a proposed biosimilar to Stelara® (ustekinumab). This marks the first ustekinumab biosimilar developed by a Chinese company to reach this stage of regulatory review in both the US and EU. A BLA seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA).
The applications are based on a comprehensive data package encompassing analytical, non-clinical, and clinical studies designed to demonstrate biosimilarity to the reference product, Stelara®.
Clinical Data Supporting Biosimilarity
The clinical data supporting the BLA and MAA include results from a randomized, double-blind, single-dose, three-arm, parallel group Phase 1 study. This study compared the pharmacokinetics, safety, and immunogenicity of BAT2206 with both the EU and US reference ustekinumab in healthy volunteers. Additionally, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study was conducted in subjects with moderate to severe plaque psoriasis (搜索). The Phase 3 trial aimed to establish equivalent efficacy and comparable pharmacokinetic, safety, and immunogenicity profiles between BAT2206 and ustekinumab.
Ustekinumab and its Clinical Applications
Ustekinumab is a human monoclonal antibody that inhibits the bioactivity of human IL-12 (搜索) and IL-23 (搜索) by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease (搜索) and ulcerative colitis (搜索), among many other autoimmune diseases. Stelara® is approved in the United States for the treatment of moderate to severe plaque psoriasis (搜索), active psoriatic arthritis (搜索), moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis in adult patients. It is also approved for moderate to severe plaque psoriasis and active psoriatic arthritis in pediatric patients 6 years and older.
Bio-Thera's Perspective
"The acceptance of both the FDA BLA and the EMA MAA for BAT2206 marks a milestone for Bio-Thera as it is the first ustekinumab biosimilar developed by a Chinese company to be submitted to the FDA or EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions (搜索). "Bio-Thera is committed to helping patients around the world in need of affordable therapeutics like ustekinumab by developing BAT2206 for the global markets."