A fast-growing class of therapeutic drugs called biosimilars is creating expanded treatment options in certain instances. The result may help lower costs for some patients and the health care system overall.
For example, the availability of Humira® biosimilars is one of the biggest opportunities in years to lower costs and increase accessibility for people who need high-cost specialty drugs.
Biosimilars are safe, effective medications for treating many illnesses, including, certain types of cancers, diabetes, Crohn’s disease, colitis, psoriasis, and rheumatoid arthritis, according to the U.S. Food and Drug Administration (FDA).
Here are answers to some of the most frequently asked questions about biosimilars:
What are biosimilars? Biosimilar drugs are biological products, meaning they use living organisms as ingredients. While they aren’t identical to their brand-name counterpart, sometimes called the reference product, they are highly similar and have no meaningful clinical differences in their active components.
Compared with a reference product, biosimilars:
- Are made with the same types of natural sources
- Have the same strength and dosage
- Provide the same treatment benefits
- Have the same potential side effects
What makes biosimilars different from generic drugs? Unlike biosimilars, generic drugs are created from synthesized chemicals. They include the same active ingredients as their brand-name comparisons and work to create the same clinical benefits.
Biosimilars are sometimes compared to generic drugs because both are versions of other FDA-approved medications that the agency says may provide more treatment options and potentially reduce costs for patients.
How are biosimilars approved for use? All FDA-approved biological products, including reference products and biosimilars, undergo a rigorous evaluation so patients can be assured of their efficacy, safety and quality. More than 40 biosimilars have been approved, although some are not commercially available.
It’s worth noting, a 2010 law does allow for an abbreviated regulatory process for biological products, including biosimilars. However, manufacturers of proposed biosimilar products still must generate data comparing the proposed product to the FDA-approved reference product to demonstrate biosimilarity and obtain approval.
How do biosimilars help drive down costs? Congress created the FDA approval pathway for biosimilar medications, in part, to help bring down prices. Because of the legislation, manufacturers do not need to conduct as many expensive and lengthy clinical trials, which may mean faster access to products, more therapeutic options and potentially reduced costs for patients.
Additionally, biosimilars may create a more competitive pricing environment among drug manufacturers, which may also help drive down drug costs. For example, UnitedHealthcare has announced that up to three biosimilars for Humira, a drug commonly used for conditions like rheumatoid arthritis and plaque psoriasis, will be added to the same tier as Humira on Prescription Drug Lists.
Is it safe to take a biosimilar if I originally started treatment on the brand-name counterpart? The FDA says biosimilar medications can generally be used even if you were originally treated with the reference product. The agency recommends talking to your health care provider about available treatment options and potential risks and benefits.
For more about biosimilars, visit the FDA website.