By Chad Pettit, executive director, Global Value Access and Policy, Amgen Biosimilars Business Unit
As expected, COVID-19 is placing tremendous pressure on our nation’s healthcare system.
The American Hospital Association estimates U.S. hospitals and health systems face a total four-month financial impact of more than $200 billion in losses.1 Experts suggest state budget shortfalls could reach 25 percent in fiscal year 2021 based on economic projections.2 And our daily conversations continue to expose the tangible impact on local businesses and the workforce. Between hospital closures, care disruptions, and wage losses that are impacting patients’ ability to bear out-of-pocket healthcare costs, the pandemic’s impact on healthcare will be long-lasting.3,4
Those are harsh figures. While the situation may seem dim, this pressure also brings vast opportunity: It has challenged our country to thoughtfully address the future sustainability of our healthcare system. That’s incredibly important.
One longstanding concern impacting the sustainability of our healthcare system is cost of care due to the burden of disease. That’s why biosimilars are so promising. During this period of COVID-19-driven budget pressure, competition supported by the introduction of reliably supplied, high-quality biosimilars in the marketplace has the potential to alleviate some of the financial burden for governments, hospitals, and patients, while delivering the needed clinical benefits of biologic medicines.6 We know that biosimilars can reduce spending by creating competition in the biologics marketplace, leading to potentially lower-cost treatment options and by creating savings from competition that can be redeployed toward spending on new, innovative therapies, including COVID-19 vaccines, treatments, and rapid testing kits, among other areas. Essentially, the introduction of biosimilars offers potential benefits to every stakeholder in the healthcare system.6
In terms of healthcare costs, biosimilars are expected to have saved the EU up to $44 billion by the end of this year.7 In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years.8 And as more biosimilars reach the marketplace, Amgen expects to see significant savings driven by competition with originator products and between biosimilars.9
Will Government Incentives Spur Biosimilar Uptake?
With savings in sight, some policymakers and industry voices think biosimilars should receive special government incentives — such as increased physician reimbursement relative to the originator product — to increase the uptake of biosimilars.10 However, government intervention is unnecessary. A reimbursement landscape that promotes competition already exists in the U.S., so additional government intervention could disincentivize competition and stifle growth — the exact opposite of what biosimilar medicines are intended to achieve.11 For example, in 2019, legislators proposed adjusting Part B reimbursement for each biosimilar for the first five years it's on the market at average sales price (ASP) plus 8 percent of the reference biologic price instead of ASP plus 6 percent. Implementing this policy would create less incentive for manufacturers to compete on price, because new biosimilars would automatically be favored over those already on the market.12
Here are some prime examples of how the reimbursement of biologic medicines is functioning properly without additional government intervention. Right now, Medicare Part B reimburses for originator and biosimilar products with separate payment codes and provides physicians the same add-on payment percentage regardless of whether they prescribe an originator or a biosimilar.13 Importantly, without interference, manufacturers already compete on delivery devices, patient services, provider education, and commitment to reliable supply. Further, commercial insurers have the tools they need to support biosimilar adoption, from formulary management to value-based programs. When manufacturers are able to compete on multiple criteria, such as comparative and real-world data, support services, product attributes, and compliance with high manufacturing standards, therapeutic choice is ultimately preserved by physicians and patients. The Biologics Price Competition and Innovation Act (BPCIA) was developed in part to broaden treatment options — and therapeutic choice can be undermined without competition on a level playing field.
Supporters of government intervention for biosimilars typically claim that the U.S. marketplace lags behind the EU. Yet, with benefit of hindsight, it turns out that nine years past enactment of the BPCIA, the U.S. biosimilar marketplace is more robust than the European market at the same point in time.14 During the first nine years of the U.S. pathway, the FDA approved 26 biosimilars referencing nine different biologics, with 12 available on the market.15,16 In comparison, in the first nine years of the EU biosimilar pathway, the European Medicines Agency approved 18 biosimilars, referencing six biologics.17
This year represents a major turning point, too. We’ve begun to see a critical mass of options that unleash competitive market forces. Last year alone, the FDA approved a record-setting 10 biosimilars — a tremendous accomplishment and a 53 percent jump from the previous year. As of July 14, 2020, the FDA has approved a total of 28 biosimilars and 18 have launched in the U.S..15,18,29 Further, there are currently more than 79 biosimilars enrolled in the FDA’s Biosimilars Program, indicating many launches are coming.20
Biosimilar Market Is Poised For Growth
With this growing number of biosimilar approvals and a robust pipeline of products from a number of companies, the IQVIA Institute estimates that competition in the U.S. biosimilar marketplace will be nearly three times greater in 2023 than it is today — all while delivering billions in savings to patients, purchasers, and insurers.8 So far, we’ve seen manufacturers launch biosimilars at a wholesale acquisition cost (WAC) price that is generally 15 percent to 37 percent lower than the originator biologic WAC, and almost all biosimilar manufacturers are launching at a WAC price that is 5 percent to 20 percent below the originator biologic ASP.21 With competition, the ASPs for originator biologics are also declining over time, leading to further healthcare savings.9 Furthermore, payers are adjusting a number of plans and pharmacy benefit managers (PBMs) to replace originator biologics with biosimilars on their formularies or designating the biosimilars as preferred products.22
My company, Amgen — which manufactures both innovator and biosimilar products — has invested $2 billion across a portfolio of 10 biosimilars, including four that are FDA-approved. To date, patients are being treated with Amgen biosimilars in over 30 countries.23 The COVID-19 crisis has convinced us that the commitment we made a decade ago to develop high-quality biosimilars is now more important than ever.23 Our two currently marketed oncology biosimilars, which have a list price that is 15 percent lower than their originator biologic list price, and 12 percent lower than the originator biologic’s ASP, are gaining adoption quickly, securing nearly 30 percent of their respective share in the U.S. in the last year.19, 24 This is generating significant cost savings for both Medicare patients and commercial payers.
As an originator product manufacturer, we’ve also witnessed the impact of biosimilar competition on several originator biologics.24 Take the oncology supportive care market: filgrastim biosimilars have experienced strong adoption, and the originator biologic’s share has dropped by roughly 70 percent.8 As the oldest biosimilar class in the U.S., this progress bodes well for newer products.
The biosimilar marketplace is beginning to flourish in the U.S. and functioning as we hope free markets would. The remarkable 143 percent increase in launched biosimilars in the past year reinforces that perspective.25 Every company finds itself winning some and losing others, hallmarks of a competitive marketplace.26, 27
While we know that manufacturers, payers, and providers already have the tools and incentives they need for adoption, there is still more work to be done to ensure that prescribers fully understand what biosimilars are, how they are manufactured and developed, and how they are approved by regulators. Case in point: A 2018 survey of 442 clinicians found that 55 percent were unfamiliar with biosimilars and a 2019 survey of oncology clinicians found that 74 percent could not give a satisfactory definition of biosimilars.28, 29 Those results prove that regulators, manufacturers, physician groups, patient groups, and health systems need to invest in education to build stakeholder confidence and achieve proper use. The FDA’s regulatory pathway already provides crucial building blocks for increased confidence, and the U.S. reimbursement framework is fully sufficient to foster a competitive marketplace with biosimilars. By continuing to emphasize science-based education about biosimilars, we can help physicians, patients, and other stakeholders become confident in biosimilars as a trusted treatment option.
It’s clear that competition is robust, biosimilar market share is increasing, prices are coming down, and substantial savings are being generated. In 2020, we can say with confidence that biosimilars can help deliver a brighter future for our healthcare system. I’m certain we’ll get there, together.
- “Hospitals and Health Systems Face Unprecedented Financial Pressures Due to COVID-19: AHA.” American Hospital Association. URL: www.aha.org/guidesreports/2020-05-05-hospitals-and-health-systems-face-unprecedented-financial-pressures-due. Accessed June 2020.
- “States Grappling With Hit to Tax Collections.” Center on Budget and Policy Priorities. June 15, 2020. URL: https://www.cbpp.org/sites/default/files/atoms/files/4-2-20sfp.pdf. Accessed June 2020.
- Wang, Hansi Lo. “About Half Of U.S. Homes Lost Wages During Pandemic, Census Bureau Finds.” CapRadio. URL: www.capradio.org/news/npr/story?storyid=858908905. Accessed June 2020.
- O'Reilly, Kevin B. “COVID-19 Job Loss Could Leave 27 Million Uninsured-What to Do Now.” American Medical Association. May 18, 2020. URL: www.ama-assn.org/delivering-care/patient-support-advocacy/covid-19-job-loss-could-leave-27-million-uninsured-what-do. Accessed June 2020.
- IQVIA. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. Published May 2019. URL: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us---a-review-of-2018-outlook-to-2023.pdf?_=1593179947545. Accessed June 2020.
- Winegarden, Wayne. The Biosimilar Opportunity: A State Breakdown. October 2019. URL: https://medecon.org/wp-content/uploads/2019/10/BiosimilarSavings_web.pdf. Accessed June 2020.
- Inside Sources. Europe demonstrates benefits of a strong biosimilars marketplace. www.insidesources.com/europe-demonstrates-benefits-strong-biosimilars-marketplace/. Accessed June 2020.
- IQVIA Institute for Human Data Science. The Global Use of Medicine in 2019 and Outlook to 2023. January 29, 2019. URL: https://www.iqvia.com/institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023. Accessed June 2020.
- Bernstein Research. Global Specialty Pharma & US Biotech. Biosimilars (Jan update): US oncology adoption quick, price follows channel; EU becomes a tough market but volume spikes. Published January 28, 2020.
- The Center for Biosimilars. Biosimilar Provisions Feature Heavily in Senate Finance Bill. July 24, 2019. URL: https://www.centerforbiosimilars.com/news/biosimilar-provisions-feature-heavily-in-senate-finance-bill. Accessed June 2020.
- Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential [published online March 30, 2018]. Rand Health Q. PMCID: PMC6075809.
- BioWorld. “U.S. biosimilar market 'thriving' without government intervention.” September 3, 2019. URL: https://www.bioworld.com/articles/429575-us-biosimilar-market-thriving-without-government-intervention?v=preview. Accessed July 2020.
- Mullen P. The arrival of average sales price. Biotechnol Healthc. 2007;4(3):48-53. PMCID: PMC3541838.
- Biologics Price Competition and Innovation Act of 2009. 42 USC § 262.
- U.S. Food and Drug Administration. FDA-Approved Biosimilar Products, Biosimilar Product Information. July 2020. URL: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm. Accessed July 2020.
- Pharmacy Times. Overview of the Biosimilar Landscape. January 22, 2020. URL: https://www.pharmacytimes.com/news/overview-of-the-biosimilar-landscape. Accessed June 2020.
- Siegel, J., Royzman, I. Patterson Belknap. Published December 21, 2017. URL: https://www.biologicsblog.com/2017-biosimilar-approvals-in-europe Accessed October 16, 2019. Accessed June 2020.
- Scrip Intelligence. US Biosimilars Market Is On Solid Footing, 10 Years In. Published June 9, 2020. URL: https://scrip.pharmaintelligence.informa.com/SC142376/US-Biosimilars-Market-Is-On-Solid-Footing-10-Years-In.
- Amgen Press Release. July 18, 2019. Accessed June 2020.
- U.S. Food and Drug Administration. FDA-TRACK: Center for Drug Evaluation & Research - Pre-Approval Safety Review - Biosimilars Dashboard: Biosimilar Development Programs Enrolled in BPD Program as of FY20 Q2. March 2020. URL: https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-center-drug-evaluation-research-pre-approval-safety-review-biosimilars-dashboard. Accessed June 2020.
- Amgen Biosimilars. 2020 Biosimilar Trends Report. High-level overview of ASP/WAC trends. P. 15.
- The Center for Biosimilars. “UnitedHealthcare Will Prefer Amgen's Anticancer Biosimilars Beginning in October.” August 15, 2019. URL: https://www.centerforbiosimilars.com/news/unitedhealthcare-will-prefer-amgens-anticancer-biosimilars-beginning-in-october. Accessed June 2020.
- Data on file, Amgen; 2020.
- The Motley Fool: Amgen Inc (AMGN) Q1 2020 Earnings Call Transcript. April 2020. URL:https://www.fool.com/earnings/call-transcripts/2020/05/01/amgen-inc-amgn-q1-2020-earnings-call-transcript.aspx. Accessed June 2020.
- Amgen Biosimilars. 2020 Biosimilar Trends Report. Timeline of Approved Biosimilars and Launch Dates. P. 14.
- The Center for Biosimilars. “UnitedHealthcare Will Prefer Amgen's Anticancer Biosimilars Beginning in October.” August 15, 2019. URL: https://www.centerforbiosimilars.com/news/unitedhealthcare-will-prefer-amgens-anticancer-biosimilars-beginning-in-october#:~:text=has%20been%20updated.-,In%20its%20August%202019%20network%20bulletin%2C%20UnitedHealthcare%20indicated%20that%2C%20beginning,but%20not%20Medicare%20Advantage)%20plans. Accessed July 2020.
- The Center for Biosimilars. “Biosimilar Uptake Varies by Class of Agent.” March 20, 2020. URL: https://www.centerforbiosimilars.com/news/biosimilar-uptake-varies-by-class-of-agent. Accessed July 2020.
- Gaffney A. How comfortable are physicians with biosimilars? Not very (yet). PwC. URL: https://www.pwc.com/us/en/industries/health-industries/library/physicians-with-biosimilars.html. Published October 24, 2018. Accessed June 2020.
- Data on file, SERMO Survey Results. Amgen; 2019.
About The Author:
Chad Pettit serves as the executive director of Global Value Access and Policy for Amgen’s Biosimilars Business Unit.
For educational resources on biosimilars, see amgenbiosimilars.com and insidebiosimilars.com.