• Positive opinion from European Medicines Agency supports approval for golimumab biosimilar Gotenfia^® developed by Bio-Thera and to be marketed by STADA
• Recommendation from EMA's CHMP committee is based on a robust analytical, non-clinical and clinical data package comparing the biosimilar candidate to the Simponi^® reference product
• Bio-Thera is responsible for development, manufacturing and supply; STADA for commercialization in the EU, the UK, Switzerland and selected other countries

 -- Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars,  received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia^® (golimumab) biosimilar candidate referencing Simponi^®.

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant a marketing authorization for Gotenfia^® for several chronic inflammatory autoimmune diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and ulcerative colitis in adult patients, as well as juvenile idiopathic arthritis in for patients aged 2 years and older.

The CHMP's positive opinion will now be referred for the European Commission to grant marketing authorization for the product that was developed by Bio-Thera under the code BAT2506. Following approval, the monoclonal antibody would be supplied as 50mg/0.5mL and 100mg/mL in a pre-filled syringe. The marketing authorization would apply across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

"This CHMP positive opinion marks a significant step towards bringing competition and improving patient access to a well-established anti-TNF therapy with annual European sales in the region of €700 million," commented STADA's Global Specialty Head, Ian Henshaw. "We look forward to employing STADA's almost 20 years of experience in supplying high-quality biosimilars in Europe  ̵  not least adalimumab and ustekinumab in immunology  ̵  to bring a convenient, once-monthly treatment option to rheumatologists, gastroenterologists and the patients they serve."

"Bio-Thera is committed to being one of the premier biosimilar developers and manufacturers in the world," said Shengfeng Li, CEO of Bio-Thera Solutions. "Building on the strong presence we have established in the US through approvals and launches, this positive CHMP recommendation helps to establish Bio-Thera as a major biosimilar developer and manufacturer serving patients in Europe."

The positive CHMP opinion on Gotenfia^®/BAT2506 was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity with the reference biologic product. A randomized 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. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2506 with the reference product in terms of efficacy, pharmacokinetic, safety and immunogenicity profiles, in psoriatic arthritis (PsA) patients. Based on the totality of evidence, it was demonstrated that BAT2506 is biosimilar to its reference product.

Bio-Thera and STADA entered into a license and commercialization agreement for golimumab in May 2024. Under the terms of the agreement, Bio-Thera is responsible for the development, manufacturing and supply. STADA holds exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries. The two companies earlier this year announced an extension of their alliance to cover the immunosuppressant monoclonal antibody tocilizumab.