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Societal Benefits of Biosimilars

Some of the most difficult diseases that afflict people in the U.S., such as cancer, anemia, inflammatory bowel disease, and autoimmune disorders such as multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn’s and other inflammatory bowel diseases, are best treated with biologics. Many biologic treatments are delivered in a health care setting in the form of solutions to be injected or administered intravenously. While biologics make up a small percentage of the total number of drugs on the market, they still pose a significant health care cost, representing 23 percent of 2014 global pharmaceutical expenditures (which are in turn 9.3 percent of total U.S. health care spending). Since their origins in the 1980s, biologics have grown to be a $179 billion market in 2014 (EvaluatePharma. World Preview 2015, Outlook to 2020. 8th Edition – June 2015). This impact is predicted to grow because many new drugs under development are biologics.

The introduction of biosimilars is anticipated to help drive lower costs burdens for the U.S. health care system and help expand earlier, more consistent access to biological medicines. The RAND Corporation has projected that the introduction of biosimilar medicines in the U.S. will reduce direct spending on biologics by $44.2 billion from 2014 to 2024. Several biological medicines will go off patent by 2020, creating an opportunity to develop biosimilars from these reference products.

Benefits for Providers

The growth of the biosimilars market may provide expanded or earlier patient access to these important treatment options. These therapies have the potential to reduce financial and administrative barriers for patients although this has not yet been demonstrated given that only one biosimilar is currently available in the U.S.

Benefits for Patients

Biosimilars may offer a number of benefits for patients, including expanded insurance coverage within a class of treatments (FTC Report, June 2009) if both the reference product and biosimilar are available in a given formulary or if used in first-line therapy as permitted by the product label. This means that biologics use may increase, either as a result of earlier treatment initiation where medically appropriate or increased medication compliance. In the long term, expanded access to biologic medicines may lead to improved patient outcomes that will in turn provide significant savings to the U.S. health care system.

In the long term, expanded access to biologic medicines may lead to improved patient outcomes that will in turn provide significant savings to the U.S. health care system.

Benefits for Payers and Systems

Biosimilars have the potential to generate savings and efficiencies for health care systems, which can help expand access to biologic medicines or free up resources for other important aspects of health care, including the development and use of new medicines.

References
  1. Biologics Price Competition and Innovation Act of 2009
  2. Food and Drug Administration (FDA). Draft Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants. March 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  3. FDA. Guidance for Industry. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. May 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  4. FDA. Draft Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act. August 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  5. FDA. Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  6. FDA. Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  7. FDA. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  8. FDA. Draft Guidance for Industry. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. May 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
  9. The Moran Company. The Role of CMS Coding in the Development of the Biosimilar Market: Considerations for Policy Makers. July 2015. www.biosimilarsforum.org/moranreport
  10. Mulcahy, Andrew W., Zachary Predmore, and Soeren Mattke. The Cost Savings Potential of Biosimilar Drugs in the United States. Santa Monica, CA: RAND Corporation, 2014. http://www.rand.org/pubs/perspectives/PE127
  11. Woodcock, Janet. Biosimilar Implementation: A Progress Report from FDA. Testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate. September 17, 2015. http://www.fda.gov/NewsEvents/Testimony/ucm463036.htm
  12. European Medicines Agency. European Public Assessment Reports. Search Terms: Biosimilars, Authorised Medicine. Retrieved November 13, 2016. www.ema.euopa.eu
  13. EvaluatePharma. World Preview 2015, Outlook to 2020. 8th Edition – June 2015. Retrieved December 7, 2015. http://www.evaluategroup.com/public/reports/EvaluatePharma-World-Preview...
  14. Center for Disease Control. National health expenditures, average annual percent change, and percent distribution, by type of expenditure: United States, selected years 1960–2013. http://www.cdc.gov/nchs/data/hus/hus14.pdf#103
  15. Federal Trade Commission. Emerging Healthcare Issues: Follow-on Biologic Drug Competition. June 2009. https://www.ftc.gov/sites/default/files/documents/reports/emerging-healt...
  16. IMS Institute. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets . March 2016. https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs...