Madrid, 26 of 2026 febrero.

• The expected savings are equivalent to 10% of the public pharmaceutical bill.
• Immunology is experiencing the greatest impact, with adalimumab leading the way.
• The virtuous circle: reinvesting savings from biosimilars to expedite the entry of disruptive innovative medicines

The Spanish National Health System faces one of its greatest opportunities for efficiency: biosimilar medicines will free up €2.836 billion by 2026, according to the report “Budgetary Impact Analysis of Biosimilar Medicines in the Spanish National Health System (2020-2030).” The study uses official consumption data from the Ministry of Health and incorporates actual prices after applying discounts from public hospital tenders to reflect a realistic procurement scenario.

According to Encarna Cruz, CEO of BioSim, “this figure represents approximately 10% of annual public pharmaceutical spending, and it's not just savings: it's reinvestment capacity, access to innovation, and future sustainability.” She also noted that “the Independent Authority for Fiscal Responsibility (AIReF), in its analysis of hospital pharmaceutical spending, identified biosimilars as the most powerful efficiency tool in this area and prioritized promoting their use among the actions to be taken.”

A prudent estimate with upside potential

Spain currently has 115 authorized biosimilar medicines, corresponding to 23 active ingredients. These include key molecules in strategic therapeutic areas such as oncology, hematology, ophthalmology, and especially immunology. The estimated savings are based on the difference between the expenditure the National Health System (NHS) would incur to acquire all these drugs if there were no biosimilar competitors and the current scenario, in which biosimilars are marketed and competition leads to lower prices. To this end, the study, led by Manuel García Goñi, Professor of Economics at the Complutense University of Madrid, carries out a future projection assuming conservative market growth, as well as the evolution of the biosimilars' market penetration. "We are talking about a prudent forecast," notes Cruz, who also points out that "the figure could increase with the arrival of new biosimilars or with greater use of existing ones."

Immunology: the great engine of savings

Immune-mediated diseases hold the greatest potential for savings for the National Health System (NHS). Adalimumab leads the ranking and represents almost a third of the total savings projected for 2026. It is followed by infliximab, a long-established pillar of the biosimilars market. In third place is ustekinumab—the most recent addition to this area—which is already showing signs of generating significant budgetary benefits in pathologies such as Crohn's disease, psoriasis, and psoriatic arthritis.

The contribution to overall savings from recent launches such as ranibizumab (2023), natalizumab (2024), denosumab (2025), and omalizumab (2025) is also significant. The latter, a regular on the list of the 20 most expensive hospital medications according to the Ministry of Health, will generate savings of over €40 million this year. A similar figure (€45 million) will be generated by biosimilars of pertuzumab (indicated for HER2-positive breast cancer), which the report anticipates will be marketed this year.

Upcoming drivers of savings

Although its commercialization is not planned for the short term, the Horizon scanning BioSim also anticipates upcoming additions to the market in the oncology field. Specifically, biosimilars of pembrolizumab and nivolumab are expected to reach the European market towards the end of this decade.

However, Cruz warns of the so-called “biosimilar gap”: only about 30% of biological molecules whose patents expire attract the interest of developers. “The regulatory and incentive framework is crucial for competition. Without predictability, investment dries up,” he points out.

In this context, the future European Biotech Act, designed to strengthen the competitiveness of the biotechnology sector in the EU, could represent an opportunity to bolster the industrial base and strategic autonomy. However, the potential extension of protection periods could delay the entry of biosimilars and, consequently, postpone savings for healthcare systems.

“Each year of delay in the introduction of a biosimilar represents hundreds of millions of euros that the system fails to free up for other healthcare needs,” Cruz points out. “Europe must find a balance between incentivizing innovation and not compromising future competition.” Investing in the savings generated by biosimilars to the acquisition of innovative medicines can be a way to continue fueling a virtuous cycle from which we all benefit.".

Further information is available in the report “Budgetary impact analysis of biosimilar medicines in the Spanish National Health System (2020 - 2030)”.

This report was commissioned by BioSim and prepared independently by the consulting firm Hygeia Consulting SL (David Carcedo, Alba Villacampa, Jordi Asís Montalt), under the direction of Manuel García Goñi, Professor in the Department of Applied Economics, Structure and History at the Complutense University of Madrid. It is available for full consultation at the following address: https://biosim.es/documentos/Impacto-presupuestario-biosimilares-2020-2030.pdf