On 10 February 2026, the European Commission (EC) granted marketing authorization for two biosimilars: Bio-Thera/Stada’s Gotenfia (golimumab); and Lupin/Sandoz’s Ranluspec (ranibizumab), both received the positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 11 December 2025.
Golimumab biosimilar Gotenfia
Guangzhou-based Bio-Thera Solutions is responsible for the development, manufacturing and supply of golimumab biosimilar Gotenfia. Stada, serving as the marketing authorization holder, is responsible for the product’s commercialization in the European Union (EU), the UK, Switzerland, and selected other countries.
Golimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It is used to treat of inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and is marketed under the brand name Simponi by the originator company Janssen [1].
Gotenfia is the second golimumab approved in the EU. It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis. Gotenfia will be available as a 50 mg/0.5 mL and 100 mg/mL solution for injection in pre-filled syringes.
The positive CHMP opinion on Gotenfia/BAT2506 was based on the totality of evidence, which included a comprehensive analytical, non-clinical, and clinical data package. The comprehensive evidence demonstrated that BAT2506 is biosimilar to its reference product.
Ranibizumab biosimilar Ranluspec
Ranluspec is developed, manufactured and registered by Lupin and was approved based on the review of a comprehensive data package.
Ranibizumab is a monoclonal antibody indicated for the treatment of various retinal conditions including wet age-related macular degeneration (AMD), macular oedema, degenerative myopia, and complications arising from diabetes—all of which are eye conditions that can lead to vision loss. The reference medicine is Genentech (Roche)/Novartis’s Lucentis [2].
Lupin’s Ranluspec (ranibizumab) has now been approved for the treatment of neovascular age-related macular degeneration, visual impairment, and other retinopathies. Ranluspec will be available as a 10 mg/mL solution for injection.
The CHMP’s positive opinion is based on a comprehensive demonstration of similarity to the reference product, including detailed analytical similarity assessments and data from a robust global Phase III clinical trial. The pivotal study involved approximately 600 patients with neovascular AMD and was conducted across multiple regions, including the US, the EU, Russia, and India, reinforcing the strength of the clinical evidence.
In August 2025, Lupin announced a commercial partnership granting Sandoz exclusive rights to market Ranluspec across the European Union, excluding Germany, and semi-exclusive rights in France, where it will be commercialized jointly with Biogaran to enhance market access. Sandoz markets a separate ranibizumab biosimilar, Formycon’s Epruvy, in Germany under a different agreement.
Epruvy (ranibizumab), a biosimilar to Lucentis, was developed by Bioeq AG, which is a joint venture between Formycon AG and Polpharma Biologics.
As of February 2026, there are six ranibizumab biosimilars, including Ranluspec, approved in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 13]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 13]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
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