%0 Journal Article %T The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation %A Bego£ża Calvo %A Enrique Echevarria %A Javier Martinez-Gorostiaga %J Archive of "Therapeutic Advances in Drug Safety". %D 2018 %R 10.1177/2042098618790442 %X The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies %K biologics %K biosimilars %K immunogenicity %K interchangeability %K pharmacovigilance %K regulatory requirements %K safety %K traceability %U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6166315/