Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, has announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi® (golimumab), seeking a commercial license in the European Union (EU).

The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

"The acceptance of the EMA MAA for BAT2506 marks another milestone for Bio-Thera as it is the first golimumab biosimilar developed by a Chinese company to be submitted to the EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. 

"Bio-Thera is committed to developing biosimilars for products like golimumab for patients around the world that are in need of affordable treatments," added Li.

The MAA for BAT2506 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterisation of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity to the reference product. Additionally, a randomised double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2506 with both, the EU and US, reference product in healthy volunteers, while a randomised, double-blind, multi-dose, two-arm, parallel group Phase 3 confirmatory study compared BAT2506 to the EU golimumab reference product to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Active Psoriatic Arthritis.

Bio-Thera Solutions and STADA Arzneimittel AG entered into a commercialisation and license agreement to develop, manufacture and commercialise BAT2506 on May 28th, 2024. Under the agreement, Bio-Thera Solutions maintains responsibility for development, manufacturing, and supply of BAT2506. STADA has exclusive regulatory and commercial rights to BAT2506 in the EU, the UK, Switzerland and select other countries.