Biosimilars have been marketed in Europe since 2006 under the regulation of the EMA. In 2015, the FDA authorized the commercialization of the first biosimilar in the United States (US).
Since then, the launch of biosimilars in the European Union (EU) has led to a 44% increase in patient access to treatments in the five biggest EU markets (France, Germany, Italy, Spain and the UK).7
Currently, the EMA has authorized more than 62 biosimilar medicines. The FDA has approved more than 29 biosimilar medicines up to date.8,9 Biosimilars are gaining an increasing foothold in the global health panorama10. Bibliography:
- 10 years of biosimilar medicines: transforming healthcare. Available on: http://www.medicinesforeurope.com/news/10-years-of-biosimilar-medicines-transforming-healthcare/#_ftn2.
- European Medicines Agency. Available on: http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit.
- Food and Drug Administration. Purple Book. Lists of licensed biological products. Available on: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
- Kumar P. Similar Biologics: Global Opportunities and Issues. J Pharm Sci. 2016;19(4):552-96.