Spain's BioSim reports surge in oncology biosimilars

BioSim’s updated Horizon Scanning report, recognized by the European Commission as the sole public source tracking the biosimilar pipeline, highlights a substantial influx of new candidates in oncology and immune‑mediated diseases. The report notes that biosimilars of golimumab, pertuzumab and the insulin analogues lispro and aspart have already received EU marketing authorisation and only await national pricing decisions in Spain. Newly evaluated by the EMA’s CHMP is the first vedolizumab biosimilar for inflammatory bowel disease, while three additional oncology agents—panitumumab, ramucirumab and enfortumab vedotin—join the pipeline, expanding therapeutic options alongside trastuzumab‑deruxtecan. In the immune‑mediated field, biosimilars of secukinumab, mepolizumab, dupilumab, ixekizumab, ocrelizumab and guselkumab are also progressing.

Spain’s role is emphasised: 96 clinical trials involving biosimilars are underway at 47 Spanish centres, covering four active substances (nivolumab, ocrelizumab, pembrolizumab, daratumumab). The regions of Madrid, Andalusia and Catalonia host the most sites, with notable participation from Galicia, Extremadura and Valencia. BioSim director Encarna Cruz stresses that “continuous monitoring of biosimilar development is essential to anticipate market entry and inform decision‑making,” while Joaquín Rodrigo, president of the national association, highlights the report’s confirmation of a “very positive evolution” that broadens treatment options and supports the sustainability of Spain’s health system.