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.
Bio-Thera’s US commercialization partner Accord BioPharma submitted the BLA and would be the MA holder if BAT2506 receives approval. Accord BioPharma filed the BLA with FDA on 16th May 2025. FDA accepts 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
4) Moderately to severely active ulcerative colitis (UC) in adults who reply on corticosteroids or haven’t responded well to or have undergone 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. Bio-Thera will develop and manufacture the product in accordance with the terms of the agreement. Accord BioPharma, a U.S. specialty unit of Intas, will commercialize 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.”
FDA accepts BLA submission as it is supported by a complete 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 three-arm, single-dose, double-blind, randomized phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT2506® with both the US and EU Simponi® in healthy volunteers.A randomized, double-blind, multicenter, parallel-arm, phase III study compared EU Simponi® to BAT2506 for efficacy, safety, and immunogenicity in the patients with active psoriatic arthritis. The overall evidence proved that BAT2506 possesses similar efficacy, safety, immunogenicity, and quality as the reference product golimumab.
