1. Duke Margolis Center for Health Policy.Public workshop: pharmacodynamic biomarkers for biosimilar development and approval Accessed June 28 2022.
2. US Food and Drug Administration.Hatch waxman letters Accessed June 28 2022.
3. US Food and Drug Administration.Implementation of the biosimilars price competition and innovation act of 2009 Accessed June 28 2022.
4. European Medicines Agency.Assessment Report on extension(s) of marketing authorisation. Remsima. International nonproprietary name: infliximab Accessed June 28 2022.
5. European Medicines Agency.Biosimilar medicines: overview Accessed June 28 2022.