About Biologics " >About Biologics

Biologics have revolutionized the treatment and prevention of many disabling and life-threatening diseases. A biosimilar is a follow-on medicine of an existing biologic for which the patent has expired and exclusivity has been lost.

Biologics

Biologic medicines are developed using a complex process, as they are made by or extracted from living organisms, tissues, or cells.1  These medicines have revolutionized the treatment and prevention of many disabling and life-threatening diseases in areas such as endocrinology, oncology, immunology, ophthalmology and dermatology.1

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

The prospect of more affordable options that are as safe and efficacious as the references medicines, opens up 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.

Biosimilars

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 has to match the reference medicine in terms of quality, safety and efficacy, demonstrating no clinically meaningful differences. This is based on the “totality of evidence” concept using advanced analytical and clinical studies.5,6 Find out more about the Development of Biosimilars here.

Depending on 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.

Benefit to patients

The introduction of affordable, high-quality biosimilars can expand access to potentially life-changing medicines for patients worldwide7

Biosimilars introduce competition, which leads to innovation such as enhancements of existing medicines and development of new treatments8

Benefit to payors

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

It is estimated that biosimilars can lead to EUR 280 billion cumulative savings between 2021 and 2025 worldwide9

Benefit to Healthcare professionals

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

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.10

  1. European Medicines Agency and European Commission. Biosimilars in the EU: information guide for healthcare professionals. 2019. Available from: Biosimilars in the EU - Information guide for healthcare professionals (europa.eu) [Accessed October 2021].
  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. European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. Available from: biosimilars_report_en.pdf (medicinesforeurope.com) [Accessed October 2021]
  6. Food and Drug Administration. Information on Biosimilars. Available from: Slide 1 (fda.gov) [Accessed October 2021]
  7. National Institute for Health and Care Excellence. NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis. June 2021.Available from: NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis | News and features | News | NICE [Accessed October 2021]
  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. Yahoo! Finance. Global Medicine Spending to Reach $1.6 trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study. Available from: Global Medicine Spending to Reach $1.6 Trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study (yahoo.com) [Accessed October 2021]
  10. IQVIA Institute for Human Data Science. The Impact of Biosimilar Competition in Europe. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/emea/theimpact-of-biosimilar-competition-in-europe-iqvia.pdf [Accessed October 2021]

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