Ontology highlight
ABSTRACT:
SUBMITTER: Kos IA
PROVIDER: S-EPMC6172013 | biostudies-other | 2018
REPOSITORIES: biostudies-other
Kos Igor Age IA Azevedo Valderílio Feijó VF Neto Daniel Egg DE Kowalski Sérgio Cândido SC
Drugs in context 20181001
Biosimilar products are already approved and marketed in several countries. The Food and Drug Administration has approved ten different biosimilars, and the European Medicines Agency has approved 40. Even though this scenario has provided important experience with biosimilar products, there are still challenges and unanswered questions. Up to now, a good amount of knowledge has been gathered in order to support the importance of the totality of evidence and the construction of a biosimilarity ex ...[more]