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Biosimilars in IBD
Key Considerations for Using Biosimilars in IBD

Released: June 06, 2017

Expiration: June 05, 2018

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Biosimilars are now accepted by IBD societies worldwide to be safe and effective first-line biologic therapies for the treatment of IBD. In the United States, 3 biosimilars—infliximab-dyyb, infliximab-abda, and adalimumab-atto—have been approved for the management of IBD, although both infliximab-abda and adalimumab-atto are not yet available.

Extrapolation to IBD
All of the biosimilar approvals in IBD have been based on extrapolation, which allows a manufacturer to extend the license of its biosimilar beyond the specific setting in which it was studied to other indications approved for the originator biologic.

For example, the infliximab biosimilars were studied in ankylosing spondylitis and rheumatoid arthritis, and the adalimumab biosimilar was studied in rheumatoid arthritis and psoriasis. The results were then extrapolated to other indications, including IBD. Although many in the IBD community initially had concerns about extrapolation, we have come to appreciate that it makes sense and support it as long as there is FDA oversight. In fact, one of the reasons biosimilars were not studied in a disease such as Crohn’s is because IBD is highly heterogeneous, making it challenging to get reproducible results within a specified margin of equivalence as compared with other diseases, such as plaque psoriasis.

Switching
What about switching to a biosimilar in a patient whose disease is responding to treatment with a biologic brand product?

Based on available data, switching in one direction—that is, switching from an originator biologic to a biosimilar—is considered safe, as long as it is seamless and there is not a delay between therapies. Given that Crohn’s and colitis are chronic conditions, disease would be expected to progress if there were an interruption when switching.

However, more data are needed to understand whether it is safe for patients to make back-and-forth switches between a biologic and its biosimilar (eg, from adalimumab to adalimumab-atto and back again) or even between biosimilars of the same reference biologic (eg, between infliximab-dyyb and infliximab-abda).

To me, the primary concern would be switching from a brand product to a biosimilar in a patient whose disease has lost response. Before biosimilars were available, if a patient lost response to one TNF-α inhibitor because of antidrug antibodies, there was no harm in switching to a different TNF-α inhibitor; those antibodies do not cross-react.

Now that biosimilars are available, we have to start thinking differently.

If a patient loses response to an originator biologic because of antidrug antibodies and then switches to its biosimilar, the antidrug antibodies could cross-react with the biosimilar and cause an allergic reaction or even anaphylaxis. Therefore, if a patient loses response to the infliximab originator (for example) because of antidrug antibodies, there is a medical and safety reason not to switch to one of its biosimilars but to instead switch to a different TNF-α inhibitor, such as adalimumab.

The Future of Biosimilars in IBD
The general consensus of the Crohn’s and Colitis Foundation, the European Crohn’s and Colitis Organization, and Crohn’s and Colitis Canada is that biosimilars have the potential to save money for health systems and increase access of biologic therapies so that we are treating our patients with most effective treatments available. To this end, it is my hope that payers will work to make preauthorization/reauthorization processes seamless, as well as provide us with exception clauses, similar to the exception to skip azathioprine in favor of a biologic agent because of its well-documented risk of lymphoma.

As we await more data on the safety of back-and-forth switching between reference biologics and their biosimilars, I also think we need to be wary of automatic substitutions by hospital systems or payers without adequate communication—every patient and provider deserves to know what drugs they are on and what drugs their patients are receiving.

Your Thoughts?
I’d like to hear from you. What challenges do you see arising as more biosimilars become available for the treatment of IBD? How do you anticipate addressing these issues? I encourage readers to post their thoughts in the comments box below.

Then, see the associated frequently asked questions modules (Biosimilars FAQ and Biosimilars FAQ2) to get answers to your questions about biosimilars.

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