Bio-Thera Solutions announced that the FDA has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16th May 2026.
The BLA was submitted by Bio-Thera's US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA. Accord BioPharma filed the BLA with FDA on 16th May 2025. The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) active psoriatic arthritis (PsA) in adults, used alone or with methotrexate, 3) active ankylosing spondylitis (AS) in adults and 4) moderately to severely active ulcerative colitis (UC) in adults who depend on corticosteroids or haven't responded well to or tolerated other treatments. The BLA also requests BAT2506 be declared interchangeable with Simponi.
Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in February 2025. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Accord BioPharma, the U.S. specialty division of Intas is responsible for the commercialization of BAT2506 in the United States.
"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. "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."
The BLA submission is based on a comprehensive analytical, non-clinical, and clinical data package submitted to the FDA. Extensive analytical characterization between BAT2506 and US and EU Simponi® was conducted on structural, physicochemical, and biological properties to support bio-similarity of BAT2506. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT2506® with both the US and EU Simponi® in healthy volunteers. 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. The totality of the evidence demonstrated that BAT2506 has similar efficacy, safety, immunogenicity, and quality as the reference product golimumab.
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