The US biosimilars market is really taking off, with 4 biosimilar products launched in the past year and 7 biosimilar products (Zarxio, Inflectra, Renflexis, Fulphila, Nivestym, Retacrit, and Udenyca) in total on the market, competing with 4 originator medicines. The projected annual savings to the US healthcare system could climb to $60 billion in 2023 for a 5-year total of $153 billion. Those projections come from the IQVIA Institute for Human Data Science, which also projects a near doubling of biosimilar product competition in the US biologics marketplace by 2023.
The US biosimilars market is really taking off, with 4 biosimilar products launched in the past year and 7 biosimilar products (Zarxio, Inflectra, Renflexis, Fulphila, Nivestym, Retacrit, and Udenyca in total on the market, competing with 4 originator medicines. The projected annual savings to the US healthcare system could climb to $60 billion in 2023 for a 5-year total of $153 billion. Those projections come from the IQVIA Institute for Human Data Science, which also projects a near doubling of biosimilar product competition in the US biologics marketplace by 2023.
With 4 decades of experience developing, manufacturing, and delivering biologic medicines to patients across the globe, and with 10 biosimilar products in our portfolio, including 3 currently approved in the US and with others in development, Amgen is committed to its role in delivering these potential savings to patients and the US healthcare system.
The US market with biosimilars has embarked on a 5-year ascent with the potential for billions saved, and for a sustained glide path of additional potential savings thereafter. Lifting the market is a scientifically sound and robust regulatory framework in the United States that has produced 20 biosimilar approvals as of June 2019. There will be future approvals involving products in the FDA’s Biosimilar Development Program, which, as of May 2019, encompassed 77 manufacturer development programs, per the FDA’s Biosimilars Dashboard. In 2019, the FDA expects to review marketing applications for 9 biosimilars and 2 interchangeable biosimilars.1
Keeping the market aloft and on course to save billions greatly depends on sustained prescriber and patient confidence, achieved through current, scientifically appropriate regulatory standards for biosimilarity and interchangeability. In a recent SERMO poll, physician confidence in FDA’s 2017 draft guidance on interchangeability dropped from 70% to 46% when physicians were asked about a hypothetical scenario in which interchangeability standards were lowered. This is why the recent science-based interchangeability standards outlined in FDA’s 2019 final guidance are meaningful to biosimilar manufacturers like Amgen: because it not only provides greater certainty for our development programs and more clarity on how to demonstrate interchangeability, but it will also foster healthcare provider and patient confidence in biosimilars and interchangeable biosimilars.
Similarly, with short-acting granulocyte colony-stimulating factor (G-CSF) competitors having achieved nearly half of the market share in a little over 3-and-one-half years, long-acting G-CSF biosimilars achieving 20% market share in just 9 months, and a single epoetin alfa biosimilar achieving 12% market share in just 6 months, it is clear that the current regulatory environment and reimbursement incentives in the US are fully sufficient for biosimilars to compete and achieve uptake.2 With Medicare providing physicians the same markup regardless of whether they prescribe an originator or a biosimilar, and commercial insurers having all the tools they need to support the adoption of biosimilars, all manufacturers can compete on equal terms.3
As a manufacturer of originator biologic products as well as biosimilars, we know that there’s no need for government policies to force prescribing of biosimilars, rather than originator products, to achieve biosimilar uptake and cost savings. Rather, we need to sustain policies that are already providing the lift for a successful and sustainable market. As the current early success of the US market with biosimilars has demonstrated, head-to-head competition between biosimilars and originator biologics on a level playing field can generate meaningful savings.3-6
Science-based education about biosimilars will also promote a sustainable, robust market. Amgen has long been a strong proponent of advancing science-based educational initiatives to build stakeholder confidence. Stakeholders will benefit from information about how biosimilars are manufactured and developed, how they are approved by regulators, the concept of extrapolation, and clinical considerations for their use. Providing scientifically accurate education to all stakeholders in the biosimilars ecosystem, including healthcare providers, is crucial to driving uptake of biosimilars.
On take-off, pilots rely on checklists. So can the US market: Regulatory framework strong, confidence increased (check); competition fostered, potential savings facilitated (check); playing field level, investment continued (check); and science-based education, understanding sound (check). This is our flight to dollars saved from a robust, sustained, and growing market with biosimilars.
1. FDA. Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications, 83 Fed. Reg. 31152, 31153 [July 3, 2018], (Table 1).
2. Amgen data on file. OBU Customer Datapack, week ending May 3, 2019 (Extract date May 24, 2019), unsmoothed data.
3. Mullen P. The arrival of average sales price. Biotechnol Healthc. 2007;4(3):48-53. PMCID: PMC3541838.
4. Xcenda analysis, Estimating the financial impact of eliminating pass-through status for biosimilars under the outpatient prospective payment system [June 27, 2018], attached to Amgen comments on the CMS’ Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule for calendar year (CY) 2019, published in the Federal Register July 31, 2018. 83 Fed.Reg. 37056.
5. Market share calculated from units sold. Data obtained by Amgen from IQVIA, National Sales Perspectives/MIDAS, 2010-2018.
6. 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.