Bio-Thera Solutions has reached a significant regulatory milestone as the European Medicines Agency (EMA) accepts its Marketing Authorization Application (MAA) for BAT2506, a proposed biosimilar to Simponi® (golimumab). This development marks the first time a Chinese-developed golimumab biosimilar has been submitted for EMA approval.
The biosimilar candidate targets multiple inflammatory conditions currently treated by the reference product Simponi®, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
Comprehensive Development Program
The MAA submission is backed by extensive analytical, non-clinical, and clinical evidence demonstrating biosimilarity to Simponi®. The development program included:
- Detailed structural, physicochemical, and biological characterization
- A randomized, double-blind Phase 1 study comparing pharmacokinetics in healthy volunteers
- A Phase 3 confirmatory trial in active psoriatic arthritis patients demonstrating equivalent efficacy and comparable safety profiles
"This acceptance 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," stated 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."
Strategic Partnership for European Market
In May 2024, Bio-Thera Solutions formed a strategic alliance with STADA Arzneimittel AG for the commercialization of BAT2506. Under this agreement:
- Bio-Thera maintains responsibility for development, manufacturing, and supply
- STADA receives exclusive regulatory and commercial rights in the EU, UK, Switzerland, and select other markets
Mechanism of Action and Clinical Impact
BAT2506 is a human IgG1 monoclonal antibody targeting tumor necrosis factor alpha (TNF-α), a key pro-inflammatory molecule. The drug works by:
- Reducing inflammatory markers including C-reactive protein, Interleukin 6, and Matrix Metalloproteinase 3
- Decreasing Intercellular Adhesion Molecule 1 and Vascular Endothelial Growth Factor levels
This mechanism of action makes it effective across multiple inflammatory conditions, potentially offering a more accessible treatment option for patients requiring TNF-α inhibition therapy.
Market Implications
The acceptance of BAT2506's MAA represents a significant step forward in Bio-Thera's global expansion and commitment to developing affordable biosimilars. Success in the European market could pave the way for broader access to golimumab therapy, potentially reducing healthcare costs while maintaining therapeutic effectiveness for patients with inflammatory conditions.
