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The Potential of Biosimilars
The Potential of Biosimilars
Adopting Biosimilars With Confidence
Adopting Biosimilars With Confidence
A Route to Biosimilars
A Route to Biosimilars
Resources

References: 1. Center for Drug Evaluation and Research. 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. Published September 9, 2014. Updated August 3, 2020. Accessed October 20, 2020. 2. Medicine use and spending in the U.S.: a review of 2018 and outlook to 2023. Parsippany, NJ: IQVIA Institute for Human Data Science; 2019. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us---a-review-of-2018-outlook-to-2023.pdf. Published May 9, 2019. Accessed October 12, 2020.  3. Biosimilars action plan: balancing innovation and competition. US Food and Drug Administration: Silver Spring, MD; 2018. https://www.fda.gov/media/114574/download. Published July 18, 2018. Accessed October 12, 2020. 4. US Department of Health and Human Services, Food and Drug Administration. From our perspective: biosimilar product labeling. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling. Published July 18, 2018. Accessed October 12, 2020.  5. Association for Accessible Medicines. 2020 generic drug and biosimilars access and savings in the U.S. report. https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf. Accessed October 29, 2020. 6. US Department of Health and Human Services, Food and Drug Administration. Biosimilars drop-in articles. https://www.fda.gov/drugs/biosimilars/biosimilars-drop-articles. Published October 19, 2017. Accessed October 12, 2020. 7. Jenkins J. Office of New Drugs, Center for Drug Evaluation and Research. Biosimilars in the US: progress and promise, DIA Biosimilars 2016. https://wayback.archive-it.org/7993/20170405202142/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM526935.pdf. Published October 27, 2016. Accessed May 19, 2020. 8. US Department of Health and Human Services, Food and Drug Administration. FDA-TRACK: Biosimilars dashboard. https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-center-drug-evaluation-research-pre-approval-safety-review-biosimilars-dashboard. Updated June 30, 2020. Accessed November 5, 2020.