- 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/en/renditions/native. Accessed March 14, 2016.
- Information on Biosimilars http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/. Accessed April 27, 2016.
- 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/WC500020062.pdf. Accessed March 14, 2016.
- IMS Institute, Delivering on the Promise of Biosimilar Medicines: The Role of Functioning Competitive Markets. http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed April 27, 2016.
Biological medicines (or "biologics") are innovative treatments that have transformed the lives of millions of patients with many disabling and life-threatening diseases.1
When patents expire on branded biologics different pharmaceutical companies are allowed to make these medicines, which have become known as biosimilars. An approved biosimilar is expected to have the same safety and beneficial effects in patients as an existing biological medicine, based on advanced laboratory studies and clinical trials.1,2 Biosimilar medicines are approved by the same regulatory authorities and are manufactured following the same high quality standards as for existing biological medicines.2,3
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 payers.4
Biosimilars – the results are the same
Think of a branded biological and a biosimilar like an original key and a duplicate that a locksmith has made of it. There may be slight differences in appearance between the original key and the copy but the results are the same, both keys will fit the same