WHY BIOSIMILARS

A biosimilar is a biologic medicine that is approved based on a demonstration that it is highly similar to an FDA-approved biological medicine. These therapies are a commonsense solution to rising prescription drug costs and a lower-cost alternative to the most expensive drugs in our healthcare system.

The introduction of biosimilars in the United States may help expand access to high-quality treatment options for clinicians and patients as well as potentially reduce costs to families, caregivers, payers, and the entire health care system. There are currently 33 biosimilars with FDA-approval, 21 on the market and many more on the way.

AMERICANS NEED HEALTHCARE SAVINGS

As the next generation of generic medicines, biosimilars are a commonsense solution and cost on average 30% less than originator biologics. Biologics are the single biggest driver of prescription drug spending. They account for just two percent of prescriptions filled, but close to 40 percent of all drug spending. We can’t afford to leave savings from biosimilars on the table. But with only 21 of the 33 U.S. FDA approved biosimilars on market, the lack of access and use of these life-saving therapies is costing, rather than saving, the U.S. billions of dollars.

BIOSIMILARS HELP SAVE

Employers, providers, and patients need financial relief now more than ever. Biosimilars provide health care savings to the top 10 most expensive drugs in Medicare Part B — savings we need to help lower costs for patients, employers and Medicare.

$250
Billion

How much biosimilars could save the U.S. health care system over the next decade

$1.4
Billion

How much self-insured companies could have saved annually if insurance plans replaced just two biologics with the lower-cost biosimilars available

$1.2
Billion

How much biosimilars could save state Medicaid programs annually

Societal Benefits of Biosimilars

The introduction of biosimilars is anticipated to help lower the cost burden of biologics on the U.S. health care system, and may help expand access to biological medicines. Expiring patents for several biological medicines in the coming years will create an opportunity to develop biosimilars to these products.

Some of the most difficult diseases that afflict people in the U.S., such as cancer, anemia, inflammatory bowel disease, and autoimmune disorders such as multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn’s and other inflammatory bowel diseases, may be treated or managed with biologics. Some biologic treatments are delivered in a health care setting in the form of an injectable or a solution to be injected or administered intravenously. While biologics make up a small percentage of the total number of drugs on the market, they can be very expensive to the patients who rely on them and are a significant cost to the U.S. health care system. Since their origins in the 1980s, biologics have grown to be a $202 billion market in 2016 (EvaluatePharma. World Preview 2017, Outlook to 2022. 10th Edition – June 2017), and the overall market for biologics is expected to continue growing due to the number of new biologic drugs currently under development.

The RAND Corporation has projected that the introduction and growth of biosimilar medicines in the U.S. will reduce direct spending on biologics by $54 billion from 2017 to 2026 Expiring patents for several biological medicines in the coming years will create an opportunity to develop biosimilars to these products.

The growth of the biosimilar market will provide multiple sourcing options for health care professionals and may provide broader and possibly earlier patient access
to these important treatment options. Broader access was observed in some European markets where the number of patients treated with a given biologic (combined originator and biosimilar) increased after the introduction of biosimilars in Europe more than ten years ago. For example, the volume of filgrastim used in the U.K. has increased since biosimilar filgrastims have become available in that country (IMS, Delivering on the Potential of Biosimilar Medicines, March 2016).

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