Information for Patients
Analytical, preclinical and clinical pharmacokinetic/pharmacodynamic studies demonstrate that the active substance in the biosimilar medicine matches the reference medicine
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.
Biosimilars – the results are the same
Think of an original-brand biologic and a biosimilar like an original key and another version that a locksmith makes. Both keys produce the same result, both will fit the same lock and open the same door, even if there are slight differences between the keys.
As with all decisions about managing their condition, patients should talk with their doctor (and healthcare team) about all of the available treatment options, their safety, benefits and risks before coming to a decision about the treatment that suits them the best.
- 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.... Accessed March 14, 2016.
- Food and Drug Administration. Biosimilars [online]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped... [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.... 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... [Last accessed: June 2020].
- Biosimilars Resource Center. What are biologics? [online]. Available from: https://www.biosimilarsresourcecenter.org/faq/what-are-biologics/ [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.... 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... [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... [Last accessed: June 2020].
- Colwell J. Cancer Discov 2015;5:460.
- Data on file. Periodic safety update reports.