Biosimilars: An Alternative to Biologics
Biosimilars are supposed to offer a less-expensive option to biologic drugs for autoimmune arthritis. Do they really cost less?
A new generation of drugs was created to make expensive biologics accessible to more people with arthritis. In 2016, the U.S. Food and Drug Administration (FDA) began approving biosimilars – copycat versions of biologic drugs – to treat autoimmune forms of arthritis, including rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis.
What exactly are biosimilars, and could they really save you money? Here’s what you need to know.
Biologics and Biosimilars
Biologic drugs are genetically engineered proteins made in a lab. They differ from earlier arthritis drugs in that they block specific proteins or immune cells that fuel inflammation.
Biosimilar drugs are very similar to biologics, but they’re not exact copies. It would be impossible to duplicate biologics, which are very large and complex molecules made from living entities. To be FDA approved, a biosimilar must work in the same way, and have the same strength, dosing, and safety as the original drug (which is called the “reference” biologic).
One downside to biologic drugs has been their steep price tag. A year of treatment on one of these drugs can cost more than $15,000.
The Biologics Price Competition and Innovation Act, which was part of the 2010 Patient Protection and Affordable Care Act (ACA), created a new approval pathway for biosimilar drugs. The goal was to increase competition in the marketplace, which would hopefully translate into cost savings for consumers. So far, that hasn’t happened.
When researchers compared the cost of infliximab (Remicade) to its biosimilar, infliximab-dyyb (Inflectra), a year of Remicade cost $17,335, compared with $14,202 for Inflectra. The savings was just 18%. Because insurers don’t provide the same Medicare coverage gap discounts for biosimilars, consumers would actually have to pay nearly $1,700 more out of pocket for Inflectra.
The biosimilars market is still very new. Prices are expected to evolve over the next few years. Experts believe these drugs will eventually save insurance companies and consumers money – but how much they save depends on factors like competition in the marketplace and doctors’ willingness to prescribe these drugs.
Biosimilars still face some outstanding issues before they can fully enter the market.
Legal issues: Pharma companies spend millions of dollars to develop and patent biologic drugs. Biosimilars cut into their profits, which is why some makers of biologic drugs have sued their biosimilar rivals to keep them off the market.
Interchangeability: Biosimilars are, by definition, similar to the reference biologic drug. The FDA could go a step further by designating certain biosimilars as “interchangeable” with their biologic. Many people with arthritis, patient advocates and doctors want to ensure that providers are notified when a substitution of an interchangeable biological product occurs. Several states have passed or are considering laws governing substitutions, and the Arthritis Foundation has a position statement available to share with your state legislators.
To be considered interchangeable, the FDA will require biosimilar manufacturers to show additional safety and efficacy data about switching back and forth between the biosimilar and the reference product. None of the available biosimilars currently has this designation.
Naming: A debate has raged over what name to give the new drugs. Names need to be unique from the reference biologic for ordering, prescribing, and dispensing reasons. The fear has been that name sharing might lead to mistaken substitutions.
According to guidance from the FDA, a biosimilar’s name must contain the core name of the reference drug, plus a unique four-letter suffix. That suffix differentiates it from the reference drug and from any biosimilar of the same reference drug that might eventually come along.
Uncertain Future: How all of these factors will play out is still unclear. Whether patients, doctors and insurance companies will embrace biosimilars, and how quickly they adopt these drugs, will depend at least partly on how much money these drugs ultimately save.
For a list of available biosimilar drugs on the market, visit the FDA’s website.
FDA. Biosimilar and interchangeable products. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#highly
FDA. Considerations in demonstrating interchangeability with a reference product: Guidance for industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
Mulcahy AW. Biosimilar cost savings in the United States. Rand Health Quarterly. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075809/
National Psoriasis Foundation. Moderate to severe psoriasis and psoriatic arthritis: Biologic drugs. https://www.psoriasis.org/about-psoriasis/treatments/biologics
Yazdany J. Out-of-pocket costs for infliximab and its biosimilar for rheumatoid arthritis under Medicare Part D. https://jamanetwork.com/journals/jama/article-abstract/2698912
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