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.
  1. Proposal for the creation of the National Observatory of Biosimilar Medicines. Andalusian School of Public Health (EASP)
  2. “Health will take advantage of upcoming regulatory projects to promote the biosimilar.” diarypharma
  3. Panorama of biosimilar medicines in Spain: market dynamics, policies, evidence-based perspectives and paths to a sustainable market. Expert Opinion on Biological Therapy
  4. Annual report. Contribution of the European Medicines Agency to science, medicines and health in 2023. European Medicines Agency (EMA)
  5. Reviewing health technology assessment agencies' approaches to assessing the value of biosimilars: A report from the ISPOR Special Interest Group. Value in Health

Key figures

Biosimilar medicines in Spain

Authorized Medicines

active substances

Authorized Presentations

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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.

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