Key TakeawaysBiosimilars are lower cost alternatives to name-brand biologic pharmaceuticals.Advocates say approving biosimilars and making them accessible to patients is key to driving down drug prices in the U.S.Uptake has been slow in the U.S., due to a variety of pricing, regulatory, and competition barriers.
Key Takeaways
Biosimilars are lower cost alternatives to name-brand biologic pharmaceuticals.Advocates say approving biosimilars and making them accessible to patients is key to driving down drug prices in the U.S.Uptake has been slow in the U.S., due to a variety of pricing, regulatory, and competition barriers.
The approval of the first interchangeable biosimilar insulin product in the United States was hailed as acrucial step in lowering medical costsfor people with diabetes.
In July, the Food and Drug Administration (FDA)approvedSemglee, a biosimilar alternative to its reference product, Lantus, a brand-name insulin glargine. A biosimilar product has no clinically meaningful differences from an approved biological product, according to theFDA. The approval means that pharmacists can automatically swap the brand-name drug for Semglee.
As biosimilars slowly but surely enter the U.S. market, advocates say the increased competition will make such medication 15% to 35% cheaper and grant patients more treatment options.
How Do Different Types of Insulin Work?
Why Is Biosimilar Medicine Important?
Biologic drugshave seen revolutionary success in the U.S. and Europe. Unlike synthesized drugs, they are derived from living organisms such as a plant or animal cells, and they are often used for disease prevention or treating cancer and rare illnesses. These include therapeutic proteins, cell therapies, and vaccines.
Although effective, biologics can be costly as manufacturers often spend years developing and testing novel molecules.
To create a cheaper alternative, manufacturers can find cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug. Biosimilars are highly similar to their reference product despite differing chemical composition.
Studies have shown that biosimilars are generally safe and effective as substitutes for biologics. A 2018 review of 90 studies indicated that most publications did not report differences in immunogenicity, safety or efficacy when switching from a reference medicine to a biosimilar.
What This Means For YouStudies show that biosimilars are a safe and effective alternative to biologic pharmaceuticals. When weighing your options for injectionable medications, ask your doctor about the availability and cost savings of biosimilar alternatives.
What This Means For You
Studies show that biosimilars are a safe and effective alternative to biologic pharmaceuticals. When weighing your options for injectionable medications, ask your doctor about the availability and cost savings of biosimilar alternatives.
Top 10 Biologic Medications in the United States
Lowering Medical Costs in the United States
Americansspend$500 billion a year on prescription drugs. Biologics make up more than$250 billionof that market, despite comprising only a fraction of the marketed drugs. The U.S. alone makes up more than half of the world’s total biologic drug revenues.
Pharmaceutical companies can file patents for their biologic products, which last for 20 years. Under the BPCIA, biologics enjoy market exclusivity for 12 years and data exclusivity for four years after receiving FDA approval, which could encourage research and development for more biosimilars.
“Before the arrival of biosimilars, originator companies—those are the companies that invent the molecule for the new drug—pretty much have the market to themselves. They can charge pretty much whatever they like and they can increase their prices, year after year,”Tony Hagen, senior managing editor for The Center for Biosimilars, tells Verywell.
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Last month, President Joe Biden announced anexecutive orderto promote business competition. He called for measures to increase the use of biosimilars as part of an effort to drive down drug prices.
“I would say there’s a fair amount of bipartisanship in this arena,” Representative Kurt Schrader said at anAxiosevent.
Schrader introduced a bipartisan bill in April to incentivize an increase in the use of biosimilars. The bill, known as BIOSIM, seeks to reimburse medical providers for the money they may lose when prescribing biosimilars.
Under the current system, Medicare reimburses doctors based on the average sales price of a drug plus 6% of the reference price. Choosing the more expensive reference drug would be the more profitable choice.
Entry Barriers for Biosimilars
When other pharmaceutical companies sued AbbVie for patent abuse, the companystruck deals to ensure that biosimilars would stay out of the U.S. market until 2023, so long as the biosimilar manufacturers were allowed to sell their products earlier in Europe.
Six alternativesto Humira are slated to enter the U.S. in 2023. An analysis finds that earlier biosimilar entry would have saved the U.S. health care system $19 billion from 2016 to 2023.
In Biden’s recent executive order, he called for the FDA and Federal Trade Commission to update patent laws to prevent major drug companies from “unjustifiably” delaying entry of generic and biosimilar products.
Prior to the order, California was the first state tooutlawthis anticompetitive practice in 2019.
The European Union approved the first biosimilar product in 2006. Since then, it has approved 55 biosimilars.These products make up about 90% of the injectionable market in Europe. In comparison, the first biosimilar was approved in the U.S. in 2015, and the drugs currentlymake upabout 20% of the market.
Projections for the Future
The U.S. saw promising growth in biosimilars as six of the 22 available products were launched last year. Additionally, the FDA expanded the biosimilar category to include insulin, human growth hormone, and fertility products, which could accelerate biosimilar product development.
“In the beginning, it was forecast that you’d see savings very quickly—tens of billions of dollars from biosimilars—but that sort of hasn’t happened. We’ve had a slow growth curve with a slow introduction of biosimilars and slow market share gains,” Hagen says. “But the more recent biosimilars that have been introduced are rapidly gaining market share, and the numbers are impressive.”
8 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Food and Drug Administration.Biosimilar and Interchangeable Products.
Food and Drug Administration.Biosimilar Product Information.
Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018; 78(4):463-478. Doi:10.1007/s40265-018-0881-y.
Blackstone EA, Joseph PF.The Economics of Biosimilars. American Health & Drug Benefits. PMCID: PMC4031732.
Aitken M, Kleinrock M, Muñoz E. Biosimilars in the United States 2020-2024: competition, savings, and sustainability. IQVIA. iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024.
Committee on Oversight and Reform.Drug Pricing Investigation: AbbVie—Humira and Imbruvica, Selected Investigation Documents. 139. U.S. House of Representatives.
Moore TJ, Mouslim MC, Blunt JL, Alexander GC, Shermock KM.Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products.JAMA Intern Med.2021;181(1):52–60. doi:10.1001/jamainternmed.2020.3997
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