STADA and Bio-Thera's Golimumab Biosimilar Gotenfia Receives Positive CHMP Opinion for Multiple Autoimmune Conditions
核心洞察
The European Medicines Agency (搜索)'s CHMP committee has issued a positive opinion recommending approval for Gotenfia (搜索) (golimumab biosimilar) developed by Bio-Thera and to be marketed by STADA (搜索) across multiple autoimmune indications.
The biosimilar targets the €700 million annual European anti-TNF therapy market and will be available as a convenient once-monthly treatment option for patients with rheumatoid arthritis (搜索), psoriatic arthritis (搜索), ankylosing spondylitis (搜索), and other inflammatory conditions.
The positive recommendation was based on comprehensive Phase 1 and Phase 3 clinical studies demonstrating biosimilarity to the reference product Simponi in terms of pharmacokinetics, safety, efficacy, and immunogenicity profiles.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for Gotenfia (搜索) (golimumab biosimilar), a collaboration between STADA (搜索) and Bio-Thera Solutions (搜索) targeting multiple chronic inflammatory autoimmune diseases. The recommendation covers treatment for rheumatoid arthritis (搜索), psoriatic arthritis (搜索), ankylosing spondylitis (搜索), non-radiographic axial spondyloarthritis and ulcerative colitis (搜索) in adult patients, as well as juvenile idiopathic arthritis (搜索) in patients aged 2 years and older.
Market Impact and Commercial Strategy
The positive CHMP opinion positions Gotenfia (搜索) to compete in a substantial European market, with Ian Henshaw, STADA (搜索)'s Global Specialty Head, noting that the anti-TNF therapy segment generates annual European sales "in the region of €700 million." The biosimilar will be supplied as 50mg/0.5mL and 100mg/mL formulations in pre-filled syringes, offering a convenient once-monthly treatment option for healthcare providers and patients.
STADA (搜索) will leverage nearly two decades of European biosimilar experience, including previous launches of adalimumab and ustekinumab in immunology, to commercialize the product across 27 EU member states plus Norway, Iceland, and Liechtenstein. Bio-Thera Solutions (搜索) CEO Shengfeng Li emphasized that this European regulatory milestone helps establish the company "as a major biosimilar developer and manufacturer serving patients in Europe," building on their existing US market presence.
Clinical Development Program
The CHMP's positive opinion was supported by a comprehensive clinical development program demonstrating biosimilarity to the reference product Simponi. The evidence package included extensive analytical characterization of BAT2506's structural, physicochemical, and biological properties compared to the reference biologic.
The clinical program comprised two key studies: a randomized, double-blind, single-dose, three-arm, parallel group Phase 1 study that compared pharmacokinetics, safety and immunogenicity of BAT2506 with both EU and US reference products in healthy volunteers. Additionally, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study evaluated BAT2506 versus the reference product in psoriatic arthritis (搜索) patients, assessing efficacy, pharmacokinetic, safety and immunogenicity profiles.
Mechanism of Action and Therapeutic Benefits
Gotenfia (搜索)/BAT2506 functions as a human IgG1 monoclonal antibody targeting tumor necrosis factor alpha (搜索) (TNF-α (搜索)), a key pro-inflammatory molecule. The binding of golimumab to TNF-α results in measurable reductions in multiple inflammatory markers, including C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF).
Partnership and Manufacturing
The collaboration between Bio-Thera and STADA (搜索), formalized through a license and commercialization agreement in May 2024, establishes clear operational responsibilities. Bio-Thera maintains control over development, manufacturing and supply of the biosimilar, while STADA holds exclusive commercialization rights across the European Union, UK, Switzerland and selected other countries. The partnership has since expanded to include the immunosuppressant monoclonal antibody tocilizumab.
Regulatory Pathway Forward
The positive CHMP opinion will now be forwarded to the European Commission for final marketing authorization approval. This regulatory milestone represents a significant step in Bio-Thera's European expansion strategy, complementing the company's existing portfolio of five approved products including QLETLI (adalimumab) and BETAGRIN (bevifibatide citrate) in China, STARJEMZA (ustekinumab) in the US, and USYMRO (ustekinumab) in the EU.