References

1.

US Food and Drug Administration. FDA approves first biosimilar product Zarxio [news release]. https://wayback.archive-it.org/7993/20171105050630/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Published March 6, 2015. Accessed August 1, 2018.

2.

US Food and Drug Administration, US Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. Silver Spring, MD: US Food and Drug Administration, US Dept of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; April 2015.

3.

US Food and Drug Administration. What are generic drugs? https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs/default.htm. Updated Jun 19, 2015. Accessed August 1, 2018.

4.

Rugo HS, Linton KM, Cervi P, et al. A clinician’s guide to biosimilars in oncology. Cancer Treat Rev. 2016;46:73-79.

5.

US Food and Drug Administration. Frequently asked questions about therapeutic biological products. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm. Updated July 7, 2015. Accessed August 1, 2018.

6.

McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91(3):405-417.

7.

US Food and Drug Administration, US Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Nonproprietary Naming of Biological Products: Guidance for Industry. Silver Spring, MD: US Food and Drug Administration, US Dept of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; January 2017. Accessed August 1, 2018

8.

US Food and Drug Administration, US Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Labeling for Biosimilar Products: Guidance for Industry. Silver Spring, MD: US Food and Drug Administration, US Dept of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; July 2018. Accessed September 5, 2018.

9.

FDA PurpleBook: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf

10.

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. Updated July 20, 2018. Accessed August 1, 2018.

11.

US Food and Drug Administration, US Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry [draft guidance]. Silver Spring, MD: US Food and Drug Administration, US Dept of Health and Human Services, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; January 2017. Accessed August 1, 2018.

12.

US Food and Drug Administration. Biosimilar and Interchangeable Products. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm. Published October 23, 2017. Accessed August 9, 2018.

13.

Center for Biosimilars. CMS Reverses Its Policy on Biosimilar Reimbursement, Will Issue Unique J-Codes. https://www.centerforbiosimilars.com/news/cms-reverses-its-policy-on-biosimilars-reimbursement-will-issue-unique-jcodes. Published November 3, 2017. Accessed August 15, 2018.

14.

National Conference of State Legislators. 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. Published July 20, 2018. Accessed August 15, 2018.

15.

MedPage Today. FDA Draft Guidance Clarifies Evidentiary Standards for Interchangeable Biological Products. https://www.medpagetoday.com/resource-centers/biosimilars/draft-guidance/24. Published November 11, 2016. Accessed August 15, 2018.

16.

Managed Care. Medicare biosimilar reimbursement: Hopes for cost savings, a dream deferred. https://www.managedcaremag.com/pharmdcorner/medicare-biosimilar-reimbursement-hopes-cost-savings-dream-deferred. Published April 18, 2018. Accessed August 15, 2018.

17.

 FDA Biological Product Definitions. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581282.pdf. Accessed September 5, 2018.