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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 June 28, 2019. Accessed July 8, 2019. 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 June 6, 2019. 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 May 14, 2019. 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 January 14, 2019.  5. Association for Accessible Medicines. Overview: 2019 generic drug and biosimilars access and savings in the U.S. https://accessiblemeds.org/resources/blog/2019-generic-drug-and-biosimilars-access-savings-us-report. Published May 13, 2019. Accessed July 3, 2019. 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 23, 2017. Accessed March 26, 2019. 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. Cumulative number of biosimilar development programs in the BPD Program in the month. https://accessdata-preprod.fda.gov/scripts/FDATrack/view/track.cfm?program=cder&id=CDER-RRDS-Number-of-biosimilar-dev-programs-in-BPD-Program. Accessed May 19, 2020.