Quality Is Critical Support on Biosimilars
THE POSSIBLE VALUE OF BIOSIMILARS More Access & Potentially Lower Costs
THE POSSIBLE VALUE OF BIOSIMILARS More Access & Potentially Lower Costs

Biosimilars may offer well tolerated and effective treatment options for patients. They may also help reduce health care spending.

WHY BIOSIMILARS?
COMPARING THE EUROPEAN UNION BIOSIMILAR EXPERIENCE TO THE US MARKET

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

  • Experiences in the European Union may or may not be similar to what will occur in the US market, given the differences in health care systems
THE IMPACT OF BIOSIMILARS IN THE EUROPEAN MARKET

Over the past 10 years, biosimilars have already been approved in several countries.4-14

  • As of February 2016, 22 biosimilars have been approved in the European Union6

The possible lower cost of biosimilars may have the potential to help increase access to biologic medicines.

  • Biosimilars may help health care cost less
  • Biosimilars may help more patients get access to biologic medicines
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 24, 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 24, 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 June 24, 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. 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. 16. 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.