Madrid, July 7 of 2026.
- Panitumumab, ramucirumab and enfortumab vedotin, all with oncological indications, are being added to BioSim's Horizon Scanning after the development of their first biosimilar candidates began.
- Biosimilars in development continue to focus on oncology – with new developments in precision oncology – and on immune-mediated diseases.
The new update to BioSim's Horizon Scanning report, recognized by the European Commission as the only publicly available source that offers structured tracking of the biosimilars pipeline[1]This brings with it important new developments. In this regard, BioSim's director, Encarna Cruz, points out that 'continuous monitoring of biosimilar development is essential to anticipate their arrival on the market and facilitates planning and decision-making based on up-to-date information'.
Among the report's main findings is a high number of molecules in the final stages of the approval process. Biosimilars of golimumab, pertuzumab, and the insulins lispro and aspart have already received marketing authorization in all Member States from the European Commission and would only require the completion of the funding and pricing stage to reach the Spanish pharmaceutical market. Regarding biosimilar candidates under evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the first vedolizumab, indicated for inflammatory bowel disease, stands out as a new development.
Also noteworthy is the addition of three new active ingredients, all with oncological indications: panitumumab, ramucirumab, and enfortumab vedotin. The introduction of the latter, an antibody-drug conjugate, joins trastuzumab deruxtecan, making them two biosimilar candidates in this group of oncology drugs with high molecular specificity and selective cytotoxic mechanisms. This expands the therapeutic options in cutting-edge oncology.
The area of immune-mediated diseases is also consolidating as a niche of interest with the advancement of the development of biosimilar candidates of secukinumab, mepolizumab, dupilimumab, ixekizumab, ocrelizumab or guselkumab.
In this regard, Joaquín Rodrigo, president of the Association, emphasizes that 'this new edition of Horizon Scanning confirms that the development of biosimilars continues to evolve very positively. Each new candidate represents another step towards expanding the available therapeutic alternatives, advancing towards early treatment, and further strengthening the sustainability of the National Health System.'
Regarding the participation of Spanish healthcare centers in clinical research with biosimilars, this edition reflects the dynamism inherent in the development of biosimilar medicines. The trials for omalizumab have been completed and, therefore, are not included in this new report, which does include, as a new addition, the trial for daratumumab at the Virgen Macarena University Hospital in Seville. In summary, 47 centers have been identified participating in 96 clinical trials for four active ingredients: nivolumab, ocrelizumab, pembrolizumab, and daratumumab. This dynamism demonstrates Spain's capacity for clinical research in biosimilar medicines. Although the Community of Madrid, Andalusia, and Catalonia continue to concentrate the largest number of participants, there is also significant territorial representation in other regions such as Galicia, Extremadura, and the Valencian Community.
About BioSim's horizon scanning
The horizon scanning https://www.biosim.es/horizon-scanning/ It is updated semi-annually based on publicly available information. The report includes a methodological note containing information for the correct interpretation of the infographic.
[1] European Commission: European Health and Digital Executive Agency, Vogler, S., Walter, M., Knoll, V. and Habimana, K., Capacity building to support the uptake of biosimilars in a multistakeholder approach – AUGMENT biosimilars – Final study report, Publications Office of the European Union, 2025, https://data.europa.eu/doi/10.2925/2261232