Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has approved biosimilars for Lucentis (ranibizumab) and Actemra (tocilizumab), expanding treatment access for eye diseases and arthritis.
In June 2025, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) approved two biosimilars: Formycon’s Ranivisio, a biosimilar of Roche’s Lucentis (ranibizumab), and Fresenius Kabi’s Tyenne, a biosimilar of Roche’s Actemra (tocilizumab). These approvals are set to significantly expand patient access to essential treatments for vision-threatening eye diseases and chronic inflammatory conditions.
Ranivisio is approved for retinal disorders such as wet age-related macular degeneration, while Tyenne is the first tocilizumab biosimilar approved in Brazil, offering a new treatment option for autoimmune and arthritic diseases.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Lucentis is the originator product developed by Roche/Genentech and is a blockbuster drug with global revenue of around US$3.4 billion in 2021 [2].
Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis [3].
The launch of Ranivisio in Brazil is scheduled for Q4 2025 and will be handled by the Brazilian biopharma company Biomm. This launch will initiate a phased market rollout across Latin America for the biosimilar (also known as FYB201), following previous approvals in the Dominican Republic, El Salvador, Honduras, and Peru. Formycon has indicated that further approvals and launches in Central and South America are planned through early 2027.
The approval of Tyenne in Brazil is in addition to the authorizations already granted by major regulatory agencies in Canada, Europe and the US [4-6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
4. GaBI Online - Generics and Biosimilars Initiative. Canada approves first tocilizumab biosimilar Tyenne [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/canada-approves-first-tocilizumab-biosimilar-tyenne
5. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
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