Substitution and Interchangeability: Explaining the Terms
|Automatic substitution of biosimilars||
*In some US states, there is ongoing dialogue regarding post-dispensing notification and documentation.
†Private organization management of substitution may vary based on formulary decisions and other factors.
‡Prescribers may indicate “Dispense As Written” and patients may request the originally prescribed biologic medicine.
References: 1. EuropaBio. Guide on Biosimilars in Europe. When Science Meets Policy. www.europabio.org/sites/default/files/europabio_guide_to_biosimilars_europe_2014.pdf. Accessed January 10, 2019. 2. CADTH. Environmental Scan: International Policies on the Appropriate Use of Biosimiliar Drugs. www.cadth.ca/sites/default/files/pdf/es0333_international-policies-on-use-of-biosimilar-drugs.pdf. Accessed January 10, 2019. 3. US Food and Drug Administration. FDA. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Published April 2015. Accessed January 10, 2019. 4. National Conference of State Legislatures. State Laws and Legislation Related to Biologic Medication and Substitution of Biosimilars. www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Accessed January 10, 2019. 5. European Commission. What You Need to Know about Biosimilar Medicinal Products. www.medicinesforeurope.com/wp-content/uploads/2016/03/biosimilars_report_en.pdf. Accessed January 10, 2019.