Biosimilars and implications for pharmacy practice: Ready or not, here they come!

Biosimilar Pharmaceuticals, Biological Therapy, Therapeutic Equivalency, Pharmacists, Pharmacovigilance, Managed Care Programs, United States

1. US Food & Drug Administration. Novel Drug Approvals for 2018. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm592464.htm (accessed Mar 20, 2019).
2. Daller J. Biosimilars: A consideration of the regulations in the United States and European union. Regul Toxicol Pharm. 2016;76:199-208. https://doi.org/10.1016/j.yrtph.2015.12.013
3. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologics. Manage Decis Econ. 2007;28(4-5):439-451. https://doi.org/10.1002/mde.1352
4. CNBC. FDA approves Novartis' $2.1 million gene therapy — making it the world's most expensive drug. https://www.cnbc.com/2019/05/24/fda-approves-novartis-2-million-spinal-muscular-atrophy-gene-therapy.html (accessed May 21, 2019).
5. Li WB, Maini A, Jacobs I. Barriers to the access and use of rituximab in patients with non-hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (Basel). 2014;7(5):530-544. https://doi.org/10.3390/ph7050530
6. Association for Accessible Medications. 2018 Generic Drug Access and Savings in the U.S. https://accessiblemeds.org/sites/default/files/2018_aam_generic_drug_access_and_savings_report.pdf (accessed Jul 26, 2019).
7. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry. https://www.fda.gov/media/124907/download (accessed Aug 14, 2019).
8. Association for Accessible Medications. 2019 Generic Drug Access and Savings in the U.S. https://accessiblemeds.org/resources/blog/2019-generic-drug-and-biosimilars-access-savings-us-report (accessed Jul 26, 2019).
9. US Food & Drug Administration. Biologics License Applications (BLA) Process (CBER). https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicslicenseapplicationsblaprocess/default.htm (accessed Dec 26, 2018).
10. European Medicines Agency and European Commission. Biosimilars in the EU: Information guide for healthcare professionals. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf (accessed Jul 2, 2019).
11. Schiestl M, Zabransky M, Sörgel F. Ten years of biosimilars in Europe: Development and evolution of the regulatory pathways. Drug Des Devel Ther. 2017;11:1509-1515. https://doi.org/10.2147/DDDT.S130318
12. Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter, D. Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm. 2019;25(1):102-112. https://doi.org/10.18553/jmcp.2019.25.1.102
13. Aladul MI, Fitzpatrick RW, Chapman SR. Patients’ understanding and attitudes towards infliximab and etanercept biosimilars: result of a uk web-based survey. BioDrugs. 2017;31(5):439-446. https://doi.org/10.1007/s40259-017-0238-1
14. Cohen JP, Felix AE, Riggs K, Gupta A. Barriers to market uptake of biosimilars in the US. GaBI J. 2014;3(3):108-115. https://doi.org/10.5639/gabij.2014.0303.028
15. Regulatory Affairs Professionals Society. Access to Biosimilars in EU Expected to Continue to Outpace US and Canada. https://www.raps.org/news-and-articles/news-articles/2018/4/access-to-biosimilars-in-eu-expected-to-continue-t (accessed Jul 26, 2019).
16. Journal of Clinical Pathways. News: IQVIA Data Show Biosimilars Struggling for Market Share in the US. https://www.journalofclinicalpathways.com/news/iqvia-data-show-biosimilars-struggling-market-share-us (accessed Jul 26, 2019).
17. Endocrineweb. America’s First Biosimilar Insulin: Coming to Your Drug Store. https://www.endocrineweb.com/news/diabetes/20555-coming-your-drugstore-americas-first-biosimilar-insulin (accessed Jul 31, 2019).
18. US Food & Drug Administration. Purple Book: Lists of Licensed Biological Products. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or (accessed May 15, 2019).
19. National Conference of State Legislatures. State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx (accessed Jul 5, 2019).
20. NBC News. Future is in doubt for cheaper versions of biologic drugs. https://www.nbcnews.com/health/health-news/future-doubt-cheaper-versions-biologic-drugs-n1023211 (accessed Jul 19, 2019).