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Christos E Emmanouilides
Christos E Emmanouilides
Greece
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Review Article
Pharmacovigilance for Biosimilars
Author(s): Maria I Karampola and Christos E EmmanouilidesMaria I Karampola and Christos E Emmanouilides
Pharmacovigilance can be defined as the process of collection of safety and to a lesser extent efficacy information regarding pharmaceuticals that have already been launched in the market. It is possible that all toxicity has not been precisely identified before drugs obtain approval for marketing. In addition to relying in ad hoc toxicity reporting, formal studies may be conducted after drug approval to confirm safety (post-authorization safety study, PASS), as well as efficacy (post-authorization efficacy study, PAES). These studies are of paramount importance for biosimilars, due to their macromolecular and potential immunogenic nature. Biosimilars are used in many medical fields, including oncology and rheumatology. In order to guarantee the success of post-authorization studies, both health care professionals and patients are required t.. View More»
DOI: 10.4172/2329-6887.1000196