1. FDA Center for Drug Evaluation and Research. (2019).List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date.https://www.fda.gov/media/89589/download(accessed 19 November 2019).
2. FDA Center for Biologic Evaluation and Research. (2019).List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date.https://www.fda.gov/media/89426/download(accessed 14 August 2019).
3. Insulins as drugs or biologics in the USA: what difference does it make and why does it matter?;George K.;BioDrugs,2019
4. FDA. (2019).Preliminary list of approved NDAs for biological products that will be deemed to be BLAs on March 23 2020.https://www.fda.gov/media/119229/download(updated 31 August 2019; accessed 23 August 2019).
5. The state-of-play and future of antibody therapeutics