SOCIETAL BENEFITS OF BIOSIMILARS
The introduction of biosimilars is anticipated to help lower the cost burden of biologics on the U.S. health care system, and may help expand access to biological medicines. Expiring patents for several biological medicines in the coming years will create an opportunity to develop biosimilars to these products.
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, may be treated or managed with biologics. Some biologic treatments are delivered in a health care setting in the form of an injectable or a solution to be injected or administered intravenously. While biologics make up a small percentage of the total number of drugs on the market, they can be very expensive to the patients who rely on them and are a significant cost to the U.S. health care system. Since their origins in the 1980s, biologics have grown to be a $202 billion market in 2016 (EvaluatePharma. World Preview 2017, Outlook to 2022. 10th Edition – June 2017), and the overall market for biologics is expected to continue growing due to the number of new biologic drugs currently under development.
The RAND Corporation has projected that the introduction and growth of biosimilar medicines in the U.S. will reduce direct spending on biologics by $54 billion from 2017 to 2026 Expiring patents for several biological medicines in the coming years will create an opportunity to develop biosimilars to these products.
The growth of the biosimilar market will provide multiple sourcing options for health care professionals and may provide broader and possibly earlier patient access to these important treatment options. Broader access was observed in some European markets where the number of patients treated with a given biologic (combined originator and biosimilar) increased after the introduction of biosimilars in Europe more than ten years ago. For example, the volume of filgrastim used in the U.K. has increased since biosimilar filgrastims have become available in that country (IMS, Delivering on the Potential of Biosimilar Medicines, March 2016).
The availability of biosimilars introduces competition, which provides more treatment options and may help to bring down prices. The availability of affordable biosimilars may improve access, and enable more patients to be treated with these therapies. Data have shown that in some indications for which biologics may be used, the use of biologics earlier in a treatment regimen (e.g. by lessening or eliminating step therapy) may improve individual patient outcomes when compared to patients not treated with biologics until later in the treatment cycle.
The availability of affordable biosimilars may improve access, and enable more patients to be treated with these therapies.
The introduction of biosimilars on the market means more treatment options and increased competition. This competition may lead to high-value therapies at reduced prices. Industry experts have suggested the savings obtained with biosimilars could free up health care funding for coverage of new medicines or other health care needs.
- Biologics Price Competition and Innovation Act of 2009
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM407844.pdf
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
- FDA. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
- 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf
- 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
- 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
- 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
- European Medicines Agency. European Public Assessment Reports. Search Terms: Biosimilars, Authorised Medicine. Retrieved November 13, 2016. www.ema.europa.eu/ema/
- EvaluatePharma. World Preview 2017, Outlook to 2022. 10th Edition – June 2017. Retrieved September 10, 2017. http://www.evaluategroup.com/public/Reports/EvaluatePharma-World-Preview-2017.aspx
- 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
- Federal Trade Commission. Emerging Healthcare Issues: Follow-on Biologic Drug Competition. June 2009. https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf
- 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/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
- Regulations.gov. Comment from Biosimilar Medicines Group, a Medicines for Europe sector group. June 26, 2017. Retrieved October 11, 2017. https://www.regulations.gov/document?D=FDA-2017-N-2732-0006
- FDA Biosimilars Website. Accessed November 15, 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm