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
Across the US pharmaceutical landscape…
In just 5 years, originator biologics were granted…
new approvals
(2015 to 2020)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
To help reduce biologic costs4
Why biosimilars are being introduced
To help reduce biologic costs4
In 2019 alone,
generic drugs saved the US health care system...
$313
BILLION5
How generics did it
The Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman”)
Generic share of US prescriptions by year5,7
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
BIOSUSTAINABLE
Maintaining the balance between innovation and accessibility
Through the adoption of biosimilars, it is estimated the health care system could save…
$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
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
- By establishing a pathway to approval
Reducing health care costs
- By potentially lowering the overall costs of biologics through the introduction of biosimilars
Increasing options
- 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:
- Improving billing and payment code policies under Medicare Part B
- 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
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.
BIOENGAGED
Working to expand access to biologic medicines
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.
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. https://www.finance.senate.gov/imo/media/doc/37143.pdf. February 26, 2019. Accessed December 1, 2020. 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 September 9, 2014. Updated August 3, 2020. Accessed October 20, 2020. 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 October 12, 2020. 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 19, 2017. Accessed October 12, 2020. 5. Association for Accessible Medicines. 2020 generic drug and biosimilars access and savings in the U.S. report. https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf. Accessed October 29, 2020. 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-delivery-brookings-institution-release-fdas. Published July 18, 2018. Accessed October 14, 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 October 12, 2020. 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 October 12, 2020. 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 October 12, 2020. 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 October 12, 2020.
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