FDA Accepts Biosimilar Application for BAT2506, Proposed Golimumab Alternative
核心洞察
The FDA has accepted Bio-Thera Solutions (搜索)' Biologics License Application for BAT2506, a proposed biosimilar to Simponi (golimumab), with a target review completion date of May 16, 2026.
The application seeks approval for all current Simponi indications including rheumatoid arthritis (搜索), psoriatic arthritis (搜索), ankylosing spondylitis (搜索), and ulcerative colitis (搜索), with interchangeability designation requested.
BAT2506 demonstrated similar efficacy, safety, and immunogenicity to reference golimumab in comprehensive Phase I and Phase III clinical studies.
The U.S. Food and Drug Administration has accepted a Biologics License Application for BAT2506, a proposed biosimilar to Simponi (golimumab), marking another step toward expanding access to affordable autoimmune treatments. The FDA has set a target review completion date of May 16, 2026, under the Biosimilar User Fee Act.
Comprehensive Indication Coverage Sought
The BLA, submitted by Accord BioPharma (搜索) on May 16, 2025, requests approval for all currently approved Simponi presentations and indications. These include moderately to severely active rheumatoid arthritis (搜索) in adults when used with methotrexate, active psoriatic arthritis (搜索) in adults used alone or with methotrexate, active ankylosing spondylitis (搜索) in adults, and moderately to severely active ulcerative colitis (搜索) in adults who depend on corticosteroids or haven't responded well to or tolerated other treatments.
Notably, the application also requests that BAT2506 be declared interchangeable with Simponi, which would allow pharmacists to substitute the biosimilar without prescriber intervention once approved.
Clinical Evidence Supporting Biosimilarity
The BLA submission is supported by a comprehensive analytical, non-clinical, and clinical data package. Extensive analytical characterization between BAT2506 and both US and EU Simponi was conducted on structural, physicochemical, and biological properties to support biosimilarity.
The clinical program included a randomized double-blind, single-dose, three-arm, parallel Phase I study that compared the pharmacokinetics, safety, and immunogenicity of BAT2506 with both US and EU Simponi in healthy volunteers. Additionally, a multicenter, randomized, double-blind, parallel-arm Phase III study compared BAT2506 with EU Simponi for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis (搜索).
According to Bio-Thera, the totality of evidence demonstrated that BAT2506 has similar efficacy, safety, immunogenicity, and quality as the reference product golimumab.
Mechanism of Action and Clinical Impact
BAT2506 is a proposed golimumab biosimilar that targets tumor necrosis factor alpha (搜索) (TNF-α (搜索)), a pro-inflammatory molecule. As a human IgG1 monoclonal antibody, binding of golimumab to TNF-α results in reductions in multiple inflammatory markers including C-reactive protein, Interleukin 6, Intercellular Adhesion Molecule 1, Matrix Metalloproteinase 3, and Vascular Endothelial Growth Factor.
Strategic Partnership and Commercialization
Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in February 2025. Under the agreement terms, Bio-Thera is responsible for development and manufacturing, while Accord BioPharma (搜索), the U.S. specialty division of Intas, will handle commercialization in the United States and serve as the marketing authorization holder if approved.
"The FDA's acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing autoimmune patients in the USA with a high-quality, low-cost treatment option," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions (搜索). "Bio-Thera is committed to developing, manufacturing and commercializing biosimilars in the US and this marks the fourth FDA BLA that Bio-Thera has filed for a biosimilar."
Expanding Biosimilar Portfolio
This acceptance represents Bio-Thera's fourth FDA BLA submission for a biosimilar product, demonstrating the company's continued commitment to the U.S. biosimilar market. Bio-Thera has previously achieved approvals for multiple products including QLETLI (adalimumab) and BETAGRIN (bevifibatide citrate) injection in China, STARJEMZA in the US, and BAT1806/TOFIDENCE (tocilizumab) and AVZIVI (bevacizumab-tnjn) in the US.