A biological medicine (commonly referred to as a “biologic” or “biopharmaceutical”) is a pharmaceutical drug whose active substance is made by or extracted from living organisms, tissues, or cells.1

Biologic medicines have revolutionized the management of some of the most hard-to-treat diseases (cancer, anemia, and autoimmune conditions such as multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease).1

However, as developing and supplying these medicines is complex, biologics are contributing to the rising cost of healthcare, and this may restrict patient access to potentially life-saving treatments.2 

The prospect of more affordable options that match the reference medicines in terms of safety, efficacy, and quality creates opportunities for healthcare systems to expand access to biologics for more patients, free up resources for investment in new areas, and relieve pressured healthcare budgets.


A biosimilar is a successor to a biologic medicine (also known as ‘reference medicine’) for which the patent has expired and exclusivity has been lost3,4.

To be approved for use, a biosimilar must match the reference medicine in terms of safety, efficacy, and quality. Therefore, physicians and patients can expect the same clinical outcome.4 This is based on the “totality of evidence” concept using comparative analytical and functional assays.5,6 

Find out more about the Development of Biosimilars here

With suitable policies and systems implemented by countries’ healthcare authorities, biosimilars have the potential to improve access challenges faced by patients, generate cost savings for healthcare systems and increase treatment options for healthcare professionals.

Siluette of elderly woman

Benefits to Patients

Biosimilars are an important tool to increase patient access to potentially life-changing medicines.7

Siluette of young business woman

Benefits to Payers

Biosimilars introduce competition, increasing affordability of biologics which delivers savings for healthcare systems9, helping to liberate resources that can be used to improve care and fund next-generation medicines.

Siluette from a doctor

Benefits to HCPs

Introduction of biosimilars drives competition, resulting in increased treatment options and value-added services to support patient care and the healthcare community.10



Biosimilars introduce competition, which leads to innovation such as enhancements of existing medicines and development of new treatments.8


Cumulative worldwide savings due to the availability of biosimilars is estimated to reach USD 215 billion between 2021 and 2026.9

Increased choice

Between 2021 and 2029, more than 120 biologic medicines will lose exclusivity - twice the number of biologics that have come off patent over the past decade.11

  1. European Medicines Agency and European Commission. Biosimilars in the EU: information guide for healthcare professionals. 2019. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-informati… [Accessed September 2022].
  2. Dutta, B., et al. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price! BioDrugs (2019)
  3. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7
  4. Kay J. A ‘wind of change’ to biosimilars: the NOR-SWITCH trial and its extension. J Intern Med. 2019;285:693-5.
  5. Weise M, et al. Blood. 2012; 120(26):5111-1117
  6. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. 2015. Available from: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry (fda.gov) [Accessed September 2022]
  7. IMS Institute for Healthcare Informatics. Delivering on the potential of biosimilar medicines. 2016. Available from http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs… [Accessed September 2022]​
  8. Vulto AG, et al. The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review. Clin Pharmacol Ther. 2020 Oct; 108(4): 734-755 ​
  9. IQVIA. The Global Use of Medicines 2022. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-u… [Accessed September 2022]​
  10. Winegarden, W. Falling Prices: Biosimilar competition has saved billions of dollars, but policy changes can incentivize billions more. Pacific Research Institute, 2022.​
  11. IQVIA Institute for Human Data Science. The Impact of Biosimilar Competition in Europe. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/emea/the impact-of-biosimilar-competition-in-europe-iqvia.pdf [Accessed September 2022]