Information for Patients
Biological medicines (or “biologics”) are innovative treatments that have transformed the lives of millions of patients with many disabling and life-threatening diseases1.
When patents expire on original-brand biologics, different pharmaceutical companies are allowed to make these medicines, which have become known as biosimilars. An approved biosimilar is expected to match the original-brand biologic in terms of safety and efficacy, based on advanced laboratory studies, pre-clinical testing and clinical trials in patients1,2 . Biosimilar medicines are approved by the same regulatory authorities and are manufactured following the same high quality standards as for existing biological medicines2,3 .
Depending on the approaches of different healthcare authorities, biosimilar medicines have the potential to contribute to solving challenges around access to medicines for patients, physicians and payers4.
HQ/SDZ/16-0001(2)
- European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/e... [2]. Accessed March 14, 2016.
- Food and Drug Administration. Biosimilars [online]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped... [3] [Last accessed: June 2020].
- European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12... [4]. Last accessed June 2020.
- Institute of Management Services. Delivering on the promise of biosimilar medicines: The role of functioning competitive markets [online]. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Instit... [5] [Last accessed: June 2020].
- Biosimilars Resource Center. What are biologics? [online]. Available from: https://www.biosimilarsresourcecenter.org/faq/what-are-biologics/ [6] [Last accessed: June 2020].
- International Alliance of Patients’ Organizations. Briefing Paper on biological and Biosimilar Medicines. November 2013. https://www.iapo.org.uk/sites/default/files/files/IAPO%20Briefing%20Pape... [7]. Last accessed June 2020.
- Weise M, et al. Biosimilars: What clinicians should know. Blood 2012;120:5111–5117.
- World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs) [online] October 2009. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEU... [8] [Last accessed: June 2020].
- European Medicines Agency. European public assessment reports [online]. Available from: https://www.ema.europa.eu/en/search/search/field_ema_web_categories%253A... [9] [Last accessed: June 2020].
- Colwell J. Cancer Discov 2015;5:460.
- Data on file. Periodic safety update reports.