Abstract
Get full access to this article
View all access options for this article.
References
1.
2.US Food and Drug Administration . Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product . 2012 . http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf. Accessed January 15, 2018 .
3.US Food and Drug Administration . Biological product definitions . https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581282.pdf. Accessed January 12, 2018 .