Boosting biosimilar. Boosting health.
BioSim, Spanish Association of Biosimilar Medicines, is a non-profit organization whose aim is to welcome and represent all pharmaceutical companies established in Spain that research, develop, produce and/or market biosimilar medicines.
- VII National Biosimilars Conference. biosim
- Nobody imagined anything like this. biosim
- Sustainability scorecards for biosimilars in Europe 2026. IQVIA
- Biotech Act – 10 things to know. European Commission
- Definitions and classification of biosimilars in the six regions of the World Health Organization. JAMA Health Forum
Press Releases
07Jul
The development of biosimilars is expanding and anticipates a new wave of launches.
> Panitumumab, ramucirumab and enfortumab vedotin, all with oncological indications, are being added to BioSim's Horizon Scanning after the development of their first biosimilar candidates began.
> Biosimilars in development continue to focus on oncology – with new developments in precision oncology – and on immune-mediated diseases.
02Jul
Joint statement from Spanish associations in the pharmaceutical and cosmetics sectors regarding the European Directive on urban wastewater treatment
Aelmhu, Aeseg, Anefp, AseBio, BioSim, Farmaindustria and Stanpa share the environmental objective of the regulations, but we believe that the proposed extended producer responsibility regime violates the polluter pays principle and is contrary to the principles of proportionality and non-discrimination
09Jun
The biosimilars sector extends a hand to the Ministry of Health to advance the Biosimilars Plan
> In the context of the VII National Biosimilars Conference, the president of BioSim highlighted the Pharmaceutical Industry Strategy of the Ministry of Health as a roadmap to move towards a more competitive, resilient and patient-oriented healthcare ecosystem.
BioSim has put forward a proposal aimed at implementing a Biosimilars Plan in Spain that seeks a rapid adoption of these drugs.
Biosimilar medicines in figures
WHAT IS A BIOSIMILAR DRUG?
A biosimilar (or similar biological medicine) is a biological medicine equivalent in quality, efficacy and safety to an original biological medicine, called a reference product. The dosage and route of administration must be the same, and the biosimilar is authorized for all or some of the indications approved for the reference biologic.
Patient access
The main, but not the only, added value attributable to the entry of biosimilars is the possibility that a greater number of patients have access to biological treatments. In other words, due to the cost reduction compared to the original product, the main beneficiary of the incorporation of biosimilar medicines into healthcare systems are the patients.
NHS sustainability
Biological medicines have represented a notable advance in the treatment of diseases that are generally serious and chronic (but not only). In many cases, these are already therapeutically essential medicines, but whose average cost is much higher than that of chemically synthesized medicines.
Access to innovative products
The incorporation of biosimilar medicines will contribute to substantially increase patient access to innovative treatments. This greater access is produced by two mechanisms.
