“Nobody imagined anything like this”: Biosimilars celebrate two decades of exceeding expectations

• Since the approval of the first biosimilar in 2006, these medicines have exceeded all initial expectations,
• The campaign commemorates 20 years of progress that has facilitated and expedited access to biologics for thousands of patients, while freeing up €2.400 billion in 2025 alone, which can be reinvested in the healthcare system.

In 2006, the European Union marked a milestone by authorizing the world's first biosimilar medicine. There was rigor, science, and hope, but no one imagined that, 20 years later, the transformative impact of these drugs would surpass even the most optimistic forecasts. Under the motto “Nobody imagined anything like this.”The Spanish Association of Biosimilar Medicines (BioSim) is launching a digital campaign today to celebrate two decades of collective success between laboratories, health administration, health professionals and patients.

Exceeding expectations: A virtuous circle

What began as a solution to ensure the sustainability of the National Health System (NHS) has become a true medical revolution. Biosimilars, biological medicines that offer the same quality, safety, and efficacy as their original biological medicines after the patent expires, have proven to be much more than just an efficient alternative.

Joaquín Rodrigo, president of BioSim, reflects on the history of biosimilar medicines. "Twenty years ago, we envisioned a future for biosimilars, but we never imagined it would exceed our expectations in terms of clinical evidence, reach, and the generation of healthcare resources we have achieved," Rodrigo notes. "What we have accomplished is extraordinary: we have surpassed our goals of bringing biological treatments to more patients more quickly," concludes the president of BioSim.

Europe: historical leadership and global benchmark

Europe was a pioneer and is now an international leader in the use of biosimilar medicines. In Europe, we already have more than 140 authorized biosimilar medicines covering critical areas such as oncology, diabetes, multiple sclerosis, and rare diseases.

Encarna Cruz, CEO of BioSim, emphasized that “this campaign is not only a look back at the past, but also a reflection on our present, and it serves as our driving force for the future. The goal of BioSim and its 16 member companies is to continue working together so that, in another 20 years, we can once again say that reality has exceeded our highest expectations.” She continued, “It is also a recognition of the work carried out by European regulatory agencies, which designed a specific and innovative framework for the authorization of these medicines. This rigorous and demanding framework has been the foundation for the high levels of trust and confidence in biosimilars that professionals and patients enjoy today.”

Real impact on figures and quality of life

The trajectory of these 20 years has yielded milestones that have transformed the daily life of the Spanish healthcare system. The CEO of BioSim highlighted the three fundamental pillars: sustainability, access, and innovation. “In the last year alone (2025), the competition generated by biosimilars has saved the system more than 2.400 millones de euros“These resources are already being reinvested in other healthcare needs and innovation,” Cruz explains. Furthermore, “we have been able to corroborate through published studies that the arrival of biosimilars has allowed for earlier access to biological treatments in pathologies such as inflammatory bowel disease or arthropathies.” 19 months“Dramatically improving patients’ quality of life.” “But that’s not all,” the CEO concludes, “we have seen that biosimilars also represent research and innovation, as evidenced by the number of clinical trials conducted in our country and the added advantages of these medications, such as the emergence of new routes of administration and new, easier-to-use devices.”