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Biologic medicines created innovative new treatments.

Biosimilars are being created to make them less costly for more patients.2

The Biosimilars Act (also known as the Biologics Price Competition & Innovation Act of 2009, or BPCIA) passed by Congress in 2010 established a statutory pathway for approval of biosimilars.3

The Hatch-Waxman Act as analogy:
Progress is possible.

The Hatch-Waxman Act of 1984 created an abbreviated FDA approval path for generic drugs to increase patient access to treatment while helping control costs.4 By 2016, 84.6% of traditional (non-biologic) prescriptions in the US were for generics.5

The Biosimilars Act was the start.
Legislation and policy continue to facilitate change:

  • December 2016: The Cures Act (also known as the 21st Century Cures Act) was created to help accelerate development and bring new products to patients faster and more efficiently6
  • August 2017: The FDA Reauthorization Act (FDARA) provided additional funding for biosimilar medicine approvals7
  • January 2018: Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap reasserted the need for medical innovation and options, while maintaining their gold standards for safety and efficacy8
  • July 2018: A Biosimilars Action Plan is released by the FDA to promote “competition and affordability” for biologic and biosimilar medicines and maintain “a robust market” for innovation while increasing access and reducing costs9

Unique billing codes ease utilization

January 2018: The Centers for Medicare & Medicaid Services (CMS) began issuing unique J codes to each individual biosimilar product prescribed under Medicare.10

Compelling evidence from the UK:

Biosimilar versions of some leading medicines are being prescribed more than the reference biologic.11

Percent of defined daily doses of total prescriptions (all forms)
Percent of infliximab biosimilars uptake
Percent of etanercept biosimilars uptake

Tracking 2 leading biologic medicines revealed a robust uptake

  • Infliximab biosimilar doses grew to 90.40% of all infliximab forms
  • Etanercept biosimilar doses grew to 75.58% of all etanercept forms
  • This has positive implications for uptake in the US market

Biosimilars: A step towards a healthier system

Globally, the uptake of biosimilars has varied, depending on the healthcare system and payer policies in each country. But in general, prices have dropped when a biosimilar is introduced.12

It’s competition for the sake of patients, physicians, payers, and the healthcare system, replacing exclusivity with sustainability.

Patients benefit

Patients benefit

Since biosimilars came out in the EU, patient treatment with biologics has increased by as much as 100%,13 while overall prices have dropped.12

...And the system is more sustainable

...And the system is more sustainable

Estimated healthcare savings in the US due to the introduction of biosimilars range from $40 billion to $250 billion by 2025.14

  1. 1. Gottlieb S. Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap. United States Food and Drug Administration website. Accessed February 1, 2018.
  2. 2. Ryan AM. Frontiers in nonclinical drug development: biosimilars. Vet Pathol. 2015;52(2):419-426.
  3. 3. United States Food and Drug Administration website. Scientific considerations in demonstrating biosimilarity to a reference product. Accessed February 4, 2018.
  4. 4. Hamburg MA. Celebrating 30 years of easier access to cost-saving generic drugs. US Food & Drug Administration website. FDA Voice. Accessed June 6, 2018.
  5. 5. The Statistics Portal. Proportion of branded versus generic drug prescriptions dispensed in the United States from 2005 to 2016. Accessed June 6, 2018.
  6. 6. United States Food and Drug Administration website. 21st Century Cures Act. Accessed January 25, 2018.
  7. 7. Biosimilars Forum website. Biosimilars Forum applauds President Trump for signing the FDA Reauthorization Act. Accessed December 22, 2017.
  8. 8. United States Food and Drug Administration website. Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap. Accessed July 9, 2018.
  9. 9. Gottlieb S. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan. United States Food and Drug Administration website. Accessed July 19, 2018.
  10. 10. Syrop J. CMS reverses its policy on biosimilar reimbursement, will issue unique J codes. Center for Biosimilars website. Accessed January 12, 2018.
  11. 11. National Health System Business Services Authority. Medicines Optimisation Dashboard. United Kingdom. MOD/AtlasTrustsMedsOp/atlas.html. Accessed June 22, 2018.
  12. 12. Serebrov M. Biosimilars: opportunities and challenges in the US and EU. Drug, Chemical & Associated Technologies Association (DCAT®) Value Chain Insights website. Accessed April 24, 2018.
  13. 13. IMS Institute of Healthcare Informatics. Delivering on the potential of biosimilar medicines. Accessed January 25, 2018.
  14. 14. Deloitte Consulting LLP. Winning with biosimilars: Opportunities in global markets. March 2016. Accessed January 25, 2018.