About Biologics

Biologics

Biologics are produced by a complex process involving living organisms1. These medicines have revolutionized the treatment and prevention of many disabling and life-threatening diseases2: diabetes, psoriasis, arthritis, growth disorders, inflammatory digestive disorders and certain types of cancer.

However, biologics are driving the rising cost of healthcare, and this may restrict access to life-saving treatment.
The prospect of more affordable options that are safe and effective opens up opportunities for health systems to expand access to biologics for more patients, free up resources for investment in new areas, and bring relief to pressured healthcare budgets.

Biosimilars

A biosimilar is a follow-on medicine of existing biologic (also known as ‘reference biologics’) when the patent has expired1,2.

To be approved for use, a biosimilar has to match the reference medicine in terms of safety and efficacy in patients, demonstrating no clinically meaningful differences. This is done using advanced analytical, preclinical and clinical studies1,3. Depending on policies and systems implemented by countries’ healthcare authorities, biosimilar medicines 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 improves access to life-changing medicines for patients worldwide

The EU saw a 100% increase in use of biologic treatments after the introduction of biosimilars in the EU4

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

Cumulative savings over the next five years (2016-2021) in the EU5* and the US combined could range from EUR 49 billion to EUR 98 billion4

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 2016 and 2020, 225 new active substances are set to come to market worldwide, with 30% expected to be biological4. Introduction of biosimilars will generate savings that can facilitate the adoption of the new biologics.
  1. European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. Available from: http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/e... [Accessed June 2017]
  2. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7
  3. Information on Biosimilars. FDA. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelope... [Accessed June 2017]
  4. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.

*EU5 countries include France, Germany, Italy, Spain and the UK

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