Madrid, 5 June 2026.
- The Spanish Senate hosted the VII National Biosimilars Conference, which commemorates the twentieth anniversary of the arrival of biosimilars in Europe.
- Mónica García, Minister of Health, opened the event by highlighting "the success story of biosimilars as a tool for access and equity."
The 7th National Biosimilars Conference, organized by BioSim under the slogan "20 years exceeding expectations", brought together on June 4th in Madrid around 200 representatives from health administrations, health professionals, regulators, health economics experts and the pharmaceutical industry to analyze the role that biosimilars have played during the last two decades and the challenges they will face in the coming years.
The day was opened with speeches by José Manuel Aranda, First Vice President of the Senate Health Committee, who celebrated “the sector’s coming of age, a milestone in terms of accessibility and sustainability”; Mónica García, Minister of Health, insisted on going beyond the classic cost-saving approach, since “biosimilars improve capillarity and the ability to reach more patients”; and Joaquín Rodrigo, President of BioSim, who thanked the parties for their joint work as key to the consolidation of these medicines in our country.
Biosimilars as a lever to improve access
At the opening conference, Pilar Pinilla Domínguez, Program Director for Methods, Research, and Health Economics at the National Institute for Health and Care Excellence (NICE), highlighted the recent creation of the Biosimilars Taskforce, in which the regulatory agency (MHRA), the English National Health Service (NHS), NICE, and the Department of Health and Social Care (DHSC) participate. This body aims to ensure that regulatory decisions, clinical guidelines, and healthcare service management operate in an integrated manner to reduce barriers to entry for biosimilars. For NICE, biosimilars are part of a comprehensive medicines lifecycle approach, an approach that has improved access to biologic therapies for thousands of patients. Pinilla illustrated the results with two case studies: a biosimilar bevacizumab, which led to a change in the funding decision for bevacizumab plus chemotherapy in metastatic colorectal cancer, and a biosimilar natalizumab, which made it possible to extend the treatment of multiple sclerosis to a larger population group. In summary, this global strategy has positioned the United Kingdom as one of the countries with the fastest adoption of biosimilars.
Biosimilars in health and industrial policy
The first panel discussion addressed the role of biosimilars within current health and industrial policies.
Sonia García Pérez, advisor to the Directorate General of the Common Portfolio of Services of the National Health System and Pharmacy at the Ministry of Health, addressed the Ministry's intense regulatory activity and highlighted the Pharmaceutical Industry Strategy, especially the thematic working groups in which biosimilars play a leading role: public procurement and sustainability. As a new development, García announced the inclusion in the new Medicines Act of an Observatory for the use of medicines, including biosimilars, as well as the upcoming publication of a monitoring report on biosimilar and generic medicines. According to Ministry data, biosimilar penetration in hospitals is 80%, although, she added, "it has taken a long time to reach these figures." "Anticipation is fundamental to facilitating rapid market entry, and the Ministry is in the preliminary stages of implementing a tool for..." horizon scanning that allows us to anticipate the arrival of new biosimilars.”
María Jesús García, Deputy Director General for Strategic Industrial Autonomy at the Ministry of Industry and Tourism, positioned the biosimilars industry as an essential part of the pharmaceutical industrial fabric that contributes to the strategic healthcare autonomy pursued by Europe. The Deputy Director reported on the recent launch of a certification for contribution to Strategic Autonomy and mentioned the Draft Industry Law, currently under parliamentary review, which introduces new concepts such as Strategic Autonomy and Strategic Industrial Ecosystems.
Jaime Espin, professor at the Andalusian School of Public Health and reviewer of the AUGMENT report, offered the audience a summary of the main conclusions of this document, “one of the European Commission’s most ambitious projects.” This project evaluates supply and demand policies regarding biosimilar medicines in 32 European countries. Jaime highlighted profit-sharing as the most effective policy (although implemented in few countries) for achieving high rates of biosimilar utilization, and reminded the audience that ambitious supply-side policies are of little use if they are not accompanied by concrete actions to promote demand, along with monitoring indicators.
Research, development and artificial intelligence: the future of biosimilars
In the first discussion, Sol Ruiz, head of the Biological Products, Advanced Therapies and Biotechnology Division of the Spanish Agency for Medicines and Health Products, and Susana Millán, medical director of mAbxience, addressed the regulatory developments regarding the exemption from confirmatory clinical trials of efficacy for biosimilars and the future that arises for regulators with the continuous evolution of biosimilars: how to evaluate biosimilars of bispecific or conjugated antibodies, biosimilars with routes of administration different from the original, etc.
Ruiz explained that this new regulatory paradigm, in which clinical trials lose weight compared to analytical comparability and biological activity, requires a significant educational effort on the part of national agencies, scientific societies and other stakeholders, in order to maintain the same level of confidence in biosimilar medicines.
For his part, Millán pointed out that real-world evidence and artificial intelligence are acquiring an increasingly relevant role in data collection and analysis, contributing to the generation of evidence that facilitates decision-making by evaluators.
New indicators for more efficient management
The second discussion addressed innovation in proactive management applied to biosimilars and the need to incorporate new indicators that facilitate health decision-making.
Antonio López, Director General of Health of Navarra, and María José Calvo, Deputy Director General of Pharmacy and Health Products of the Madrid Health Service (SERMAS), discussed the need to incorporate new indicators of biosimilar consumption and evaluation tools for proactive management.
Both agreed on the need to move towards a more proactive and earlier approach to biosimilars management policies. Calvo addressed the need to evolve from the classic "penetration share" indicator to more sensitive and informative indicators such as the number of patients treated or the use of biosimilars by therapeutic indication—both issues currently being developed by the Madrid Health Service (SERMAS). López, for his part, pointed out that a joint effort is required to improve the culture of evaluation, and that establishing reliable and implementable dashboards and relying on clinical leadership can be key drivers for the optimal use of biosimilars. Finally, the need to begin systematically working on economic indicators that clearly demonstrate the contribution of these medicines to the sustainability of the healthcare system was raised—a message that should not be forgotten.
Biosimilars in the face of the new European regulatory scenario
Nicolás González Casares, Member of the European Parliament, gave the closing lecture focused on the major regulatory developments in Europe - beyond the pharmaceutical package - regarding medicines: the European Biotechnology Act and the Critical Medicines Act.
Casares stated that “there will be no good European Biotechnology Law if biosimilars do not occupy a central place,” since over the past 20 years they have demonstrated that competition incentivizes innovation and also makes it accessible and sustainable. He also emphasized the synergies between innovation and biosimilars as complementary areas for ensuring that the best treatments reach patients.
The event was closed by Encarnación Cruz, CEO of BioSim, who thanked all the speakers and attendees for their participation. According to Cruz, “We have made great strides in these 20 years, but we must not be complacent. There is still much room for improvement, and this event has raised several challenges: how to advance an industrial policy that favors European development and production; the need to coordinate actions between government agencies, regulators, and healthcare services to maximize the potential of biosimilars; the continuous evaluation of the life cycle of medicines as a lever for access; and the need for a change in management approach to anticipate strategies that could limit their market introduction and use.”