Citation:Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, Warnock DG. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert OpinBiolTher. 2013 Jul;13(7):1039-47. doi: 10.1517/14712598.2013.783560. Epub 2013 Mar 26. http://www.ncbi.nlm.nih.gov/pubmed/23527621
A biosimilar is a term for a drug or medicine that is derived from a biological source; insulin is one example. Biosimilars are also known as “large molecules” in contrast to small molecule synthesized drugs, and they are often very expensive. A “generic” version of an innovator biosimilar is not 100% the same as the innovator due to the biological nature of the process but it will go to market at a reduced price. The question is, is it similar enough? Will it have the same effect? Will it have the same safety profile?
This paper by Casadevall et al. reviews the EU experience with biosimilar pharmacovigilance and discusses what may occur in the United States. Different areas of pharmacovigilance are explored, such cohort event monitoring, traceability, biosimilar interchangeability, pharmacovigilance system development, nomenclature and counterfeit tracking.
Related article: Bui LA, Taylor C.Developing clinical trials for biosimilars.SeminOncol. 2014 Feb;41 Suppl 1:S15-25. doi: 10.1053/j.seminoncol.2013.12.002. Epub 2013 Dec 7.http://www.ncbi.nlm.nih.gov/pubmed/24560024