The Potential of Biosimilars

THE POTENTIAL OF

BIOSIMILARS

“We can significantly reduce spending on pharmaceuticals...by ensuring that we have a viable market for biosimilars in the United States."1
– Kenneth C. Frazier, CEO

Biologic Products Account for 36% of All US Prescription Drug Spending

Across the US pharmaceutical landscape…

In just 3 years, originator biologics were granted…

new approvals

(2016 to 2018)2

And biologic products account for

36%

of all US prescription drug spending (2018)3

Could biosimilars help reduce costs to the health care system and help with patient access to biologics?

BIORESPONSIBLE

Evolving the health care system to help meet increasing demands

Why Biosimilars Are Being Introduced

Why biosimilars are being introduced

To help reduce biologic costs4

Why biosimilars are being introduced
Why Biosimilars Are Being Introduced

To help reduce biologic costs4

In 2018 alone,

generic drugs saved the US health care system...

~$293

BILLION5

How generics did it

The Drug Price Competition and Patent Term Restoration Act (”Hatch-Waxman”)

The Influence of Hatch-Waxman (1984) Wasn't Felt Overnight. Working Together Now, We May Help Make an Impact With Biosimilars Sooner.

Generic share of US prescriptions by year7

In 1984, Congress established Hatch-Waxman to encourage competition and provide incentives for pharmaceutical innovators to develop new drugs6

~13%

in 1983

The influence of Hatch-Waxman (1984) wasn't felt overnight. Working together now, we may help make an impact with biosimilars sooner.

What generics were to the US health care system in the 20th century

is what biosimilars could become in the 21st century

What generics were to the US health care system in the 20th century is what biosimilars could become in the 21st century

What Generics Were to the US Health Care System in the 20th Century Is What Biosimilars Could Become in the 21st Century

BIOSUSTAINABLE

Maintaining the balance between innovation and accessibility

Through the Adoption of Biosimilars, the Health Care System Could Save an Estimated $54 Billion Over 10 Years

Through the adoption of biosimilars, it is expected the health care system could save an estimated…

$54

BILLION

over 10 years, from 2017 to 20268,a

aCost savings based on 2017 projection.

And biosimilars have support too

Governmental entities are actively engaged in helping to improve adoption of biosimilars across the US health care system.9,10

Governmental Entities Are Actively Engaged in Helping to Improve Adoption of Biosimilars Across the US Health Care SystemGovernmental Entities Are Actively Engaged in Helping to Improve Adoption of Biosimilars Across the US Health Care System

And biosimilars have support too

Governmental entities are actively engaged in helping to improve adoption of biosimilars across the US health care system.9,10

The Biologics Price Competition and Innovation Act (BPCIA) of 20099,10

Congress passed the BPCIA with the goals of:

Facilitating biosimilar competition

Reducing health care costs

Increasing options

Facilitating biosimilar competition

Facilitating Biosimilar Competition
  • By establishing a pathway to approval

Reducing health care costs

By Potentially Lowering the Overall Costs of Biologics Through the Introduction of Biosimilars
  • By potentially lowering the overall costs of biologics through the introduction of biosimilars

Increasing options

Increasing Options by Offering Greater Access to Medications
  • By offering greater access to medications
  • By expanding payer, provider, and patient choice

US Department of Health and Human Services (HHS)11

HHS is taking steps to help address the challenges of access to and reimbursement of biosimilars, such as:

HHS Is Taking Steps to Help Address the Challenges of Access to and Reimbursement of Biosimilars
  • Improving billing and payment code policies under Medicare Part B
Revising Medicare Part C and D Regulations to Help Increase Access to Biosimilars
  • Revising Medicare Part C and D regulations to help increase access to biosimilars

FDA’s Biosimilars Action Plan9

The FDA has laid out a multifaceted action plan to foster biologic innovation and further biosimilars development. Key measures range from the development and implementation of new FDA review tools to providing revised guidance on biosimilar topics to the establishment of a new Office of Therapeutic Biologics and Biosimilars (OTBB).

BIOPROSPECTIVE

The future looks bright

Biosimilar Adoption Could Help Lay the Groundwork for Future Generations of Breakthrough Treatments

When stakeholders throughout the health care system come together to achieve mutually beneficial goals, great things can happen.

Biosimilar adoption could help lay the groundwork for future generations of breakthrough treatments.

Biosimilar Adoption Could Help Lay the Groundwork for Future Generations of Breakthrough Treatments

BIOENGAGED

Working to expand access to biologic medicines

The Purpose of Merck Biosimilars Is to Provide High-quality Biosimilar Products to Help Meet the Cost-related Challenges of the Health Care System and to Provide More Options to Providers and Their Parents

The goal of Merck biosimilars...

The purpose of Merck biosimilars is twofold. We are committed to providing high-quality biosimilar products to help meet the cost-related challenges of the health care system and to provide more options to providers and their patients.

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References: 1. US Senate Committee on Finance. Testimony of Kenneth C. Frazier, CEO, Merck & Co., Inc. Drug pricing in America: a prescription for change, part II. February 26, 2019. 2. Center for Drug Evaluation and Research. List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date. https://www.fda.gov/media/89589/download. Published June 28, 2019. Accessed July 8, 2019. 3. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. Parsippany, NJ: IQVIA Institute for Human Data Science; 2019. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us---a-review-of-2018-outlook-to-2023.pdf. Published May 9, 2019. Accessed June 6, 2019. 4. US Department of Health and Human Services, Food and Drug Administration. Biosimilars drop-in articles. https://www.fda.gov/drugs/biosimilars/biosimilars-drop-articles. Published October 23, 2017. Accessed March 26, 2019. 5. Association for Accessible Medicines. Overview: 2019 generic drug and biosimilars access and savings in the U.S. https://accessiblemeds.org/resources/blog/2019-generic-drug-and-biosimilars-access-savings-us-report. Published May 13, 2019. Accessed July 3, 2019. 6. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469–478. 7. US Department of Health and Human Services, Food and Drug Administration. 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. https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-deliverybrookings-institution-release-fdas. Published July 18, 2018. Accessed May 19, 2020. 8. Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. https://www.rand.org/content/dam/rand/pubs/perspectives/PE200/PE264/RAND_PE264.pdf. Published October 23, 2017. Accessed May 8, 2019. 9. Biosimilars Action Plan: Balancing Innovation and Competition. US Food and Drug Administration: Silver Spring, MD; 2018. https://www.fda.gov/media/114574/download. Published July 18, 2018. Accessed May 14, 2019. 10. US Department of Health and Human Services, Food and Drug Administration. From our perspective: biosimilar product labeling. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling. Published July 18, 2018. Accessed January 14, 2019. 11. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. US Department of Health and Human Services: Washington, DC; 2018. https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf. Published May 11, 2018. Accessed May 30, 2019.