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THE POTENTIAL OF BIOSIMILARS Payers Play a Critical Role in Biosimilar Uptake
THE POTENTIAL OF BIOSIMILARS Payers Play a Critical Role in Biosimilar Uptake
THE GOALS FOR CREATING AN APPROVAL PATHWAY FOR BIOSIMILARS IN THE UNITED STATES

A pathway for approving biosimilars was created by the US Biologics Price Competition and Innovation Act (BPCIA) of 2009.1

Biosimilars have been approved for use in several countries and as of February 2016, 22 biosimilars have been approved in the European Union.4-14

PAYER BIOSIMILAR POLICIES IN SELECTED EUROPEAN MARKETS

Payer policies have varied considerably across Europe, and each global market operates using a different framework for funding and decision-making. This structural variability can lead to important differences in the influences and incentives for the adoption of biosimilars.15

Discounting biosimilars is one way to affect adoption rates, but EU payers have numerous tools that also help influence the adoption of biosimilars.15

TRANSLATING THE EU AND CANADIAN EXPERIENCE TO THE US MARKET

How the introduction of biosimilars will affect pricing and patient access in the US remains to be seen.

  • History of introduction and use in the EU market may or may not translate to the US market given the marked differences in health care systems
BIOSIMILAR DECISION POINTS15
COMPETITION IS IMPORTANT: LEARNINGS FROM THE EUROPEAN MARKET*

Payer biosimilar polices in selected European markets have helped ensure strong biosimilar uptake and foster sustainable competition.16

*Sourced from IMS Health, January 2016.
BIOSIMILARS HAVE IMPACTED DRUG PRICES AND PATIENT ACCESS IN THE EUROPEAN MARKET

At the request of the European Commission, IMS Health investigated the impact of biosimilar competition on drug price, volume, and market share in Europe.17

Global Impact of Biosimilars

Biosimilars in Canada

References:
1. Title VII—Improving Access to Innovative Medical Therapies. Subtitle A—Biologics Price Competition and Innovation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf. Accessed June 3, 2016. 2. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed June 3, 2016. 3. US FDA. From our perspective. Biosimilar product labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm. Accessed June 3, 2016. 4. Generics and Biosimilars Initiative. Biosimilars approved in Canada. http://www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada. Accessed May 3, 2016. 5. Generics and Biosimilars Initiative. Biosimilars approved in the US. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US. Accessed May 3, 2016. 6. Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America. http://www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America. Accessed May 3, 2016. 7. Generics and Biosimilars Initiative. Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed May 3, 2016. 8. Generics and Biosimilars Initiative. Trastuzumab non-originator biological approved in Russia. http://www.gabionline.net/Biosimilars/News/Trastuzumab-non-originator-biological-approved-in-Russia. Accessed May 3, 2016. 9. Generics and Biosimilars Initiative. Iran approves its first rituximab biogeneric. http://www.gabionline.net/Biosimilars/News/Iran-approves-its-first-rituximab-biogeneric. Accessed May 3, 2016. 10. Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India. http://www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India. Accessed May 3, 2016. 11. Generics and Biosimilars Initiative. Biosimilars approved in South Korea. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea. Accessed May 3, 2016. 12. Generics and Biosimilars Initiative. Biosimilars approved in Japan. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan. Accessed May 3, 2016. 13. Generics and Biosimilars Initiative. Biosimilars approved in Australia. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia. Accessed May 3, 2016. 14. Generics and Biosimilars Initiative. Biosimilars approved in New Zealand. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-New-Zealand. Accessed May 3, 2016. 15. Precision for value. Impact of market access factors in the adoption of biosimilar anti-TNFs across Europe. Academy of Managed Care Pharmacy (AMCP) Managed Care & Specialty Pharmacy annual meeting. San Francisco, CA; April 19-22, 2016. http://www.precisionforvalue.com/wp-content/uploads/2016/05/Impact-of-Market-Access-Factors-Across-Europe.pdf. Accessed June 27, 2016. 16. IMS Health. Delivering on the potential of biosimilar medicines; the role of functioning competitive markets. https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed June 27, 2016. 17. IMS Health. The impact of biosimilar competition. http://ec.europa.eu/DocsRoom/documents/14547/attachments/1/translations/en/renditions/native. Published November 2015. Accessed June 3, 2016. 18. IMS Health. The impact of biosimilar competition–five observations by IMS Health. http://ec.europa.eu/DocsRoom/documents/14548/attachments/1/translations/en/renditions/native. Accessed June 3, 2016. 19. Intellectual Asset Management. Biosimilars in Canada: at a tipping point. http://www.iam-media.com/Intelligence/IAM-Life-Sciences/2016/Articles/Biosimilars-in-Canada-at-a-tipping-point?vl=1150040789. Accessed June 27, 2016. 20. Drug Coverage. A guide to reimbursement. http://www.drugcoverage.ca/en-ca/. Accessed July 12, 2016. 21. Health Canada. Provincial and territorial public drug benefit programs. http://www.hc-sc.gc.ca/hcs-sss/pharma/acces/ptprogeng.php. Accessed June 27, 2016. 22. Subsequent entry biologics (SEBs) first principles. PM Provinces Territoires. http://www.pmprovincesterritoires.ca/phocadownload/pcpa/2016/seb_first_principles_20160401.pdf. Accessed July 12, 2016. 23. Green Shield Canada. GSC Update. Introducing Green Shield Canada’s (GSC) subsequent-entry biologic policy. http://www.greenshield.ca/en-ca/news/newsroom/introducing-green-shield-canada-s-gsc-s-subsequent-entry-biologic-policy. Accessed June 27, 2016.