Biosimilars role in IBD treatment

Have you received a notification from your insurance carrier that coverage of your specialty medication is changing? If so, you aren’t the only one. Many of my patients who are on biologics have been informed by their insurer that they are now required to switch to a biosimilar. I know this can sound scary, especially if you’ve been on your medication for a while and are doing well. As a patient myself, I know firsthand how hard it is to find a medication that works and keeps your symptoms at bay, so any changes to your treatment regimen can bring uncertainty and a lot of questions and concerns. But I want you to know that biosimilars are just as safe and effective as other Food & Drug Administration (FDA) approved biologics.   

What are biosimilars?

If you aren’t familiar, biosimilars are medications that are designed to be near-identical, “highly-similar” copies of approved biological therapies (known as reference product or the originator biologic). They have the same effectiveness and safety as the originator biologic and are taken in the same form (still given as an IV infusion, the same dose, and the same rate or length of the infusion). It’s important that patients understand that there are no clinically meaningful differences between the biosimilar and the originator. The FDA has approved 10 biosimilars to treat IBD, and three are currently available to patients. The others will become available in the next few years.

Are biosimilars safe and effective?

Biosimilars first entered the market five years ago, and the data supports the safety and efficacy of these medications in the treatment of IBD. Specifically:

• Studies support the use of intravenous (IV) anti-TNF biosimilars to treat IBD for new starts (patients who haven’t been on an IV anti-TNF biologic before). 
• Studies support the safety and efficacy of a one-time switch from the originator biologic to a biosimilar if that patient has completed the initial induction/loading dosing, has adequate drug levels, and is in clinical remission.
• Studies support that switching from the originator biologic to a biosimilar does not increase loss of response, worsen clinical symptoms, increase risk of side effects, or antibody production.

The Crohn’s & Colitis Foundation is not opposed to new starts and single transitions of patients in clinical remission from the originator biologic to a biosimilar (or vice versa) or from a biosimilar to another biosimilar by third parties (insurers or pharmacies). However, when a switch occurs, patients and their providers must be informed of the exact medication the patient is receiving well in advance. However, the Foundation is opposed to multiple switches between the originator biologic and biosimilars due to the lack of data supporting the safety and efficacy of such treatment strategy in patients with IBD. You can read more in the Foundation’s biosimilar position statement.

Because of the safety and efficacy data available, I do not have concerns about putting my patients on a biosimilar or switching them from the originator biologic to a biosimilar if the patient is in clinical remission, on a stable dose, and have therapeutic levels. I also recommend monitoring disease status and drug levels post switch. Ultimately, I believe this decision to switch should be a decision between the patient and their provider. 

I understand that you or your loved one may feel hesitant or unsure of making a switch to a biosimilar – especially if your current treatment plan is working well. That’s completely normal, and I encourage you to share your concerns with your doctor, including asking them about your ability to appeal the decision. The appeals process can take time and may cause significant delays in your care, so make sure you ask your healthcare team about the process and review all possible options. If you decide to go that route, I encourage you to explore the Crohn's & Colitis Foundation’s resources on insurance appeals to learn more about the process. 

So…what should you do when you are informed by your insurer that you need to switch to a biosimilar?

Make sure you tell your healthcare team that your insurance company is requiring that you change to a biosimilar and confirm that this change in your treatment is right for you. In addition, your insurer will likely require your provider and you to seek a prior authorization for the biosimilar. If you have already switched to a biosimilar, and your insurer is asking you to switch again, notify your insurer and your provider that you have already done a single switch. Some insurers have established programs to ensure patients are not inadvertently switched multiple times. Here are some helpful questions you may want to ask your healthcare team: 

• Do you recommend that I switch to the biosimilar medication?
• Will my hospital/clinic/infusion center administer the new biosimilar medication?
• Will the biosimilar cost the same as the originator?
• Is there any reason why I may need a medical exemption to stay on the originator?
• When and how will this change take place?
• Does the biosimilar have a co-pay program or financial assistance program I can take advantage of?
• Should I expect any changes in my symptoms after I switch to a biosimilar?
• I have already switched once before, should I be switching again? 

Remember, treatment decisions should be shared between you and your provider, so keep them in the loop if your insurer wants to switch you to a biosimilar. If you remember only one thing from this blog post, I hope it’s that biosimilars are safe and effective treatment options for IBD patients. 

Click here for more information on biosimilars and contact the Foundation’s IBD Help Center for assistance or to share your experience with biosimilars.