Understanding biosimilars
If you have recently switched from a biologic drug to a biosimilar rest assured that the biosimilar is approved by the U.S. Food and Drug Administration (FDA) and has the same active ingredients as the original biologic, also called a reference biologic. The biosimilar works the same way and has similar potential side effects.
Biosimilars play a critical role in helping to keep prescription costs affordable. Like generic medications, they are typically much less expensive than the original biologic or brand-name medication while still providing the same treatment benefit. For example, Wellmark’s preferred Humira® biosimilar, adalimumab-aacf, is a fraction of the price of Humira. Most Wellmark members who use adalimumab-aacf will pay less or their copay will remain the same when moving to the biosimilar.
Biological medications (biologics and biosimilars) are made from natural and living sources and microorganisms and are typically more complex than other medications. They can be made of living cells, tissues, sugars and proteins.
They are used to treat chronic and severe conditions. Some of the most common biologics treat various autoimmune diseases, cancers and diabetes.
To receive FDA approval, studies must demonstrate that there are “no differences in the safety and effectiveness of biosimilars and the original biologics,” according to the FDA. Once a biosimilar has been approved, the FDA continues to ensure its safety by checking quality indicators during the manufacturing process and tracking patient safety reports made to the agency.
Wellmark’s Pharmacy & Therapeutics (P&T) Committee, which is made up of licensed, practicing physicians and pharmacists in Iowa and South Dakota, also review every drug placed on Wellmark’s drug list for safety and effectiveness.
Per FDA.gov, there are more than 60 FDA-approved biosimilars available for use in the United States today.
Wellmark members may have already received a biosimilar as an injection or infusion from their provider since biosimilars first became available in the United States in 2015. These include drugs used to treat cancer, autoimmune diseases and many other conditions.
What are the differences between a biologic and a biosimilar?
- A biosimilar is a highly similar version of an FDA-approved biologic medicine.
- Patients can expect the same safety, effectiveness and quality as the original biologic.
- Using biosimilars may help lower health care costs while maintaining the same treatment goals.
Yes, they are just as safe. Regulatory groups like the U.S. Food and Drug Administration (FDA) test biosimilars to prove there are no meaningful differences in safety, purity, or potency compared to the original drugs.
How They Compare
- Safety level: Both carry the same types of potential side effects and health risks.
- Effectiveness: Both work equally well to treat complex medical problems like cancer, diabetes, and arthritis.
- Manufacturing: Both are made using living cells and can have tiny, natural variations between production batches.
- Cost: Biosimilars often cost less money for patients and health systems.