1. 2015 Food and Drug Administration’s Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product.
2. Wang YC, Wang Y, et al. Role of modeling and simulation in the development of novel and biosimilar therapeutic proteins. J Pharm Sci. 2018.
3. 2016 Food and Drug Administration’s Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product.
4. Obianom O, Okusanya O, Earp J, Thway T. Evaluation of the impact of bioanalytical bias difference between proposed biosimilar and reference products on the outcome of pharmacokinetic similarity studies. Submitted to Clinical pharmacology and therapeutic journal.
5. 2018 Food and Drug Administration Guidance for Industry: bioanalytical Method Validation https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry