Ontology highlight
ABSTRACT:
SUBMITTER: Paramsothy S
PROVIDER: S-EPMC5193082 | biostudies-other | 2016 Dec
REPOSITORIES: biostudies-other
Paramsothy Sudarshan S Cleveland Noa Krugliak NK Zmeter Nada N Rubin David T DT
Gastroenterology & hepatology 20161201 12
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formu ...[more]