|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. European Commission. What you need to know about biosimilar medicinal products. www.medicinesforeurope.com/wp-content/uploads/2016/03/biosimilars_report_en.pdf. Accessed October 29, 2019. 2. European Medicines Agency. Biosimilars in the EU: information guide for healthcare professionals. www.ema.europa.eu/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed October 29, 2019. 3. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. www.fda.gov.downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537135.pdf. Accessed October 29, 2019. 4. US Food and Drug Administration. Biosimilar and interchangeable products. www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed October 29, 2019.