You may have heard about “biosimilars” in conversations with providers or in broader healthcare news but wondered what they are. Although biosimilars are already widely used in some areas of medicine, their role in bleeding disorders care is evolving.
Still, learning about them and why they matter can help you feel more informed if these therapies become part of your treatment discussions.
What Is a Biosimilar?
A biosimilar medication is highly similar to an approved biologic drug, known as a reference product. According to the U.S. Food and Drug Administration (FDA), biosimilars must show “no clinically meaningful differences” from the original biologic in terms of safety and effectiveness.
These are not the same as generic drugs. Generic medications are chemical copies of traditional medicines, such as acetaminophen. Biologics are more complex because they are made from living cells or microorganisms, so they can’t be copied. Instead, biosimilars are designed to work similarly to biologics.
That distinction matters in the bleeding disorders community, because many treatments are biologic. Recombinant factor products for hemophilia A and B are biologics, as are nonfactor therapies including monoclonal antibody treatments, such as emicizumab.
Why Am I Hearing About Biosimilars Now?
The National Bleeding Disorders Foundation (NBDF) has been monitoring the topic for years. In 2012, NBDF’s Medical and Scientific Advisory Council (MASAC) released a statement on biosimilars that highlights the importance of patient safety, careful monitoring, and informed decision-making when discussing biologic products and biosimilars. Those factors are still relevant today.
Increasingly across healthcare, biologic medications are among the most expensive therapies. Biosimilars are intended to add more options, which may help improve access and reduce costs over time.
These potential benefits are the main reasons that biosimilars have become a growing topic around bleeding disorders, even though biosimilar use in the community is relatively limited compared with conditions such as cancer and arthritis. Studies have shown that biosimilars are effective in treating hemophilia A and idiopathic thrombocytopenic purpura.
Are Biosimilars Safe?
In short, yes. To be approved by the FDA, biosimilars must go through rigorous testing to demonstrate that they are highly similar to the original biologic product and not clinically different in terms of safety and effectiveness.
The approval process for a biosimilar is generally shorter than it is for the original biologic product, because the manufacturer only needs to demonstrate biosimilarity to the original. The FDA says this saves the manufacturer from having to do as many expensive and lengthy clinical trials.
A biosimilar may be designated as “interchangeable” by the FDA, meaning it can be substituted for the original biologic without intervention of the prescribing provider. However, state pharmacy laws can affect how interchangeable products are used in practice.
Can I Switch to a Biosimilar?
Many people with bleeding disorders develop trust in a therapy over years of successful treatment, which can make the prospect of switching therapies feel especially significant in this community.
It’s important to understand that biosimilars are designed to match the original biologic product’s safety and effectiveness as closely as possible. So, they won’t necessarily be more effective, but they may have better insurance coverage or lower cost than your current treatments.
Conversations about switching therapies may involve treatment history, bleed control, inhibitor history, insurance coverage, and comfort level with a particular product. You should feel good about asking questions and discussing any concerns with your comprehensive care team before making changes to your treatment plan.
What Questions Should I Ask My Provider About Biosimilars?
As biosimilars become part of broader healthcare discussions, patients and caregivers can benefit from staying informed and involved in treatment decisions. Questions to ask your provider team include:
- Is this treatment a biologic, a biosimilar, or an interchangeable biosimilar?
- Why is this therapy being recommended?
- Has the FDA approved this product as a biosimilar or interchangeable biosimilar?
- Could insurance coverage affect my treatment options?
- What should I know before switching therapies?
- What experience does my care team have with this type of therapy?
- How will my treatment plan change?
Although biosimilars are not as common for bleeding disorders as for other medical conditions, it’s a good idea to be familiar with them and to understand how they might be used in your care.