Biological medicinal products are proteins that are obtained from living cells (such as fluids, human or animal tissue, microorganisms, etc.). They work by interacting with the body to produce a therapeutic effect via different mechanisms depending on the medicinal product and its indications. (1)
As we have seen in previous posts, a biosimilar, or similar biological medicinal product, is a biological medicinal product that is equivalent in terms of quality, efficacy and safety to its reference biological medicinal product, i.e. it contains a version of the biological active substance from an authorised original medicinal product. (1)
The European Union (EU) has been a pioneer in the regulation of biosimilar medicinal products, which is reflected in the number of biosimilars that have been approved within its borders.
European legislation does not detail the type or amount of clinical and non-clinical data that are required to approve a biosimilar medicinal product. Instead, each specific case undergoes a personalised evaluation according to scientific guidelines. (1)
The first scientific directive drafted was a general guideline that came into effect in October 2005. Subsequently, general guidelines on the quality of clinical and non-clinical data were created and, ultimately, various annexes have been published on specific clinical and non-clinical requirements for each specific class of products. Similar regulations have been extended to other countries, such as the FDA (Food and Drug Administration) in the United States, which implements similar guidelines. (2)
There are currently more biosimilars approved in the EU than anywhere else worldwide. Since the first biosimilar was approved in 2006, 39 biosimilars (corresponding to 13 active substances) have been approved. In 2017, the EMA (European Medicines Agency) has approved 17 new biosimilars, 2 of which are in the final stages of approval, in contrast to the United States, where 7 biosimilars in total have been authorised to date, three of which this year. (3,4,5,6)
They are developed based on existing scientific knowledge of reference biological medicinal products, so it is not necessary to repeat all the clinical studies conducted with the original medicinal product. This means that the development costs are lower, so biosimilars can be offered at a lower price with no detrimental effect on their quality, efficacy or safety. (1)
In this respect, biosimilars represent an opportunity to reduce pressure on healthcare costs, contribute to the sustainability and efficiency of health systems and increase the availability and patients access to biological medicinal products. (1)
(1)Introducción de los biosimilares en España. Estimación del ahorro para el sistema nacional de salud. Fundación Weber. Noviembre 2017.
(2)Libro blanco de los medicamentos biosimilares en España. Fundación Gaspar Casal. 2014
(4)http://www.ema.europa.eu/ema/index.jsp?mid=WC0b01ac058001d124&searchType=name&taxonomyPath=&genericsKeywordSearch=Submit&searchGenericType=biosimilars&keyword=Enter+keywords&alreadyLoaded=true&curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&status=Authorised&treeNumber=&searchTab=searchByAuthType&pageNo=1 Last access 24/11/2017
(6) https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved /ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm Last accessÚltimo acceso 24/11/2017