Benefit of biosimilar switching ‘less apparent’ to GIs, patients vs. third-party payers
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If you see more than a few patients with inflammatory bowel disease, you likely already have been asked by a third-party payer to switch a patient’s adalimumab prescription from the reference product to a biosimilar.
My short message to you: Yes, it is annoying, but in most cases it’s OK to switch.
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The FDA’s biosimilar approval pathway uses a combination of structural, analytical, in vitro and abbreviated clinical testing — including pharmacokinetic testing — to show that a biosimilar drug is highly similar in efficacy, safety and immunogenicity to the reference product.
We already have witnessed significant uptake of infliximab biosimilars in the United States, although interestingly their uptake has been slower than that of most other biosimilar drugs, such as Genentech’s Avastin (bevacizumab), Herceptin (trastuzumab) or Rituxan (rituximab). We as providers in the U.S. also have had the benefit of seeing the 5-year Humira (adalimumab, AbbVie) biosimilar experience in Europe, which overall has been quite favorable.
A few of the adalimumab biosimilars have primary data in Crohn’s disease, with head-to-head studies comparing the biosimilar with the originator. Those studies show basically identical efficacy and safety. I don’t think any of us have any concerns about starting a new patient on an adalimumab biosimilar. The switching studies, some of which are retrospective, suggest acceptable outcomes, such that in most scenarios it would be reasonable to switch a patient from originator to biosimilar — if asked to do so.
“I am not going to switch someone if I don’t have to switch someone” would be the best way to summarize my take on this. “However, if asked to switch, I will do so.”
To me, it’s not going to be worth expending the time, energy and resources appealing a denial if there is not a valid reason for doing so.
The term “interchangeable” is a specific federal designation that means a biosimilar has been tested prospectively with multiple switches. A much smaller number of drugs have this designation. Time will tell if this will really be important or not.
As Stephen B. Hanauer, MD, points out in the Healio exclusive, most of the biosimilars have become de facto interchangeable if the third-party payer is pushing the switch. However, the federal interchangeable designation in some cases will allow pharmacists to make a switch, theoretically without notifying the patient or provider.
Ultimately, the availability of biosimilars that are less expensive than originator drugs will benefit the U.S. health care system, but unfortunately, those benefits may be less apparent to the individual provider or patient. Nevertheless, I will willingly use biosimilars in scenarios where I need to use them.
- For more information:
- Edward V. Loftus Jr., MD, is the Maxine and Jack Zarrow Family Professor of Gastroenterology at the Mayo Clinic. He can be reached at loftus.edward@mayo.edu.
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