Madrid, January 29 of 2026

• The European report 'Capacity building to support the uptake of biosimilars in a multistakeholder approach' indicates that BioSim is the only identified public source that provides detailed data by active ingredient on biosimilars in the pipeline.
• The new report from January 2026 incorporates six new active ingredients, including trastuzumab deruxtecan, the first biosimilar candidate of an antibody conjugate.

The Spanish Association of Biosimilar Medicines, BioSim, has published the first 2026 update of its 'Horizon Scanning' report, an essential tool for healthcare planning that has recently received definitive international support. The European Commission report entitled “Capacity building to support the uptake of biosimilars in a multistakeholder approach” explicitly cites BioSim's work as an exception in the European landscape.

According to the Commission document, “publicly available information on biosimilars in development remains scarce in Europe [...] the only identified public source that provides data by active ingredient on biosimilars in development is the information system maintained by the Spanish biosimilars industry association (BioSim).”

BioSim's president, Joaquín Rodrigo, emphasizes the significance of this recognition: “Being singled out by the European Commission as the benchmark for transparency and foresight across the continent reinforces our commitment to generating knowledge that supports informed decision-making. Horizon Scanning is not just a list of drugs; it's a compass for managers and professionals to prepare for the arrival of competition, optimizing resources from day one.”

Highs and lows: The new wave of biosimilars

The January 2026 update reflects the market's dynamism. Following their recent market launch at the end of 2025, denosumab and aflibercept, two molecules with a large number of biosimilars already on the market, are no longer included in the report.

Conversely, the report includes six new active ingredients with innovations that mark the beginning of a new era in high-complexity biotechnology. In the area of ​​oncology, in addition to the first preclinical candidate for atezolizumab (non-small cell lung cancer and other tumors), two candidates—also in the preclinical phase—are trastuzumab/pertuzumab and trastuzumab deruxtecan monoclonal antibody conjugate (both for the treatment of HER2+ breast cancer). Ixekizumab, risankizumab, and guselkumab, indicated for psoriasis, are also being monitored.

Also noteworthy are the pertuzumab biosimilars, which have improved their ranking compared to the previous edition. Currently, two candidates are being evaluated by the EMA, and they are expected to be the most significant new authorizations in 2026.

Encarna Cruz, CEO of BioSim, explains the importance of these additions: “The arrival of biosimilar candidates like trastuzumab deruxtecan indicates that the biosimilars industry continues to address therapies of extremely high technical complexity. This will provide additional financial relief for therapeutic areas such as oncology and immunology, where pharmaceutical spending grows year after year due to the arrival of high-cost innovations.” “Undoubtedly, it is necessary to highlight the industry's commitment to the research and development of new biosimilars, something that is not always recognized, and which directly impacts the improvement of citizens' health,” Cruz continues.

New Spanish centers on the map of clinical research with biosimilars

This new update also highlights the growing participation of Spanish hospitals in the clinical development of biosimilars, with fourteen hospitals joining the clinical research of pembrolizumab biosimilar candidates. “It is great news that Spain continues to be a hub for clinical trials with biosimilars,” Cruz points out.

About BioSim's Horizon scanning

BioSim's Horizon Scanning captures an up-to-date snapshot of biosimilars in preclinical, clinical, and European Medicines Agency (EMA) evaluation stages, and also includes—at the national level—the pre-marketing funding and pricing decision phase. The inclusion of a detailed methodological note ensures that all stakeholders in the sector, from government agencies to clinicians, have accurate information on when and why these medicines are expected to reach the National Health System (NHS).

Direct link to the Horizon Scanning publication: https://www.biosim.es/horizon-scanning/