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
Some relevant data:
- 2006: a growth hormone is the first biosimilar authorized by the EMA and commercialized in the EU.
- June 2013: infliximab biosimilars are the first biosimilar monoclonal antibodies to be authorized by the EMA.
- March 2015: the FDA approves filgrastim biosimilar, the first biosimilar authorized in the US.
- April 2016: FDA approves infliximab biosimilar, the first biosimilar monoclonal antibody to be authorized in the US.
Currently, the EMA has authorized more than 30 biosimilar medicines. The FDA has approved more than 5 biosimilar medicines up to date.8,9
Biosimilars are gaining an increasing foothold in the global health panorama10.
- 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.