ADVERTISEMENT
4 Questions About the Expected Increase in Biosimilars for IBD
Six biosimilars have been approved for adult inflammatory bowel disease (IBD)—3 for adalimumab and 3 for infliximab. As other pharmaceutical companies become interested in bringing biosimilars to market, gastroenterologists can expect the number of available biosimilars for the management of IBD to increase.
The availability of more biosimilars can be good news for patients with IBD, who may experience decreased drug costs and improved access. However, as biosimilars become more common, gastroenterologists can expect to face a few challenges.
Adam Cheifetz, MD, director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and a professor of medicine at Harvard Medical School, spoke with Gastroenterology Consultant about biosimilars following his presentation on the topic at the Advances in Inflammatory Bowel Diseases Regional Meeting in Boston, Massachusetts.
Gastroenterology Consultant: During your presentation, you mentioned that gastroenterologists should expect to see an increase in the number of available biologics. Why is that?
Adam Cheifetz: I think other companies are interested in bringing more biosimilars to market. Right now, just infliximab and adalimumab are off-patent, so those are the biosimilars that are approved by the US Food and Drug Administration (FDA). Currently in the United States, only the infliximab biosimilars are clinically available due to certain legal issues. Eventually, other biologics will come off-patent, and companies will develop other biosimilars of vedolizumab and ustekinumab.
GASTRO CON: As these biologics come off-patent, what challenges will specialists face?
AC: I think the one challenge—and where we lack data in IBD specifically—is with multiple switches between various biosimilars and the reference product. For example, a patient is started on the branded or innovator infliximab, and their insurance forces a switch to a biosimilar—call it biosimilar A. Two years later, their insurance company gets a better deal from biosimilar B and forces another switch, and 2 years after that, the branded one now becomes the preferred agent. Currently in IBD we do not have safety data on multiple switches. No interchangeable biosimilars have been approved for use in the United States by the FDA. There have been 2 studies of psoriasis where they did multiple medication switches, 1 study was with adalimumab and the other with etanercept (which we do not use for IBD). In these, efficacy and safety of multiple switches were similar.
What is the nocebo effect? >>
Six biosimilars have been approved for adult inflammatory bowel disease (IBD)—3 for adalimumab and 3 for infliximab. As other pharmaceutical companies become interested in bringing biosimilars to market, gastroenterologists can expect the number of available biosimilars for the management of IBD to increase.
The availability of more biosimilars can be good news for patients with IBD, who may experience decreased drug costs and improved access. However, as biosimilars become more common, gastroenterologists can expect to face a few challenges.
Adam Cheifetz, MD, director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and a professor of medicine at Harvard Medical School, spoke with Gastroenterology Consultant about biosimilars following his presentation on the topic at the Advances in Inflammatory Bowel Diseases Regional Meeting in Boston, Massachusetts.
Gastroenterology Consultant: During your presentation, you mentioned that gastroenterologists should expect to see an increase in the number of available biologics. Why is that?
Adam Cheifetz: I think other companies are interested in bringing more biosimilars to market. Right now, just infliximab and adalimumab are off-patent, so those are the biosimilars that are approved by the US Food and Drug Administration (FDA). Currently in the United States, only the infliximab biosimilars are clinically available due to certain legal issues. Eventually, other biologics will come off-patent, and companies will develop other biosimilars of vedolizumab and ustekinumab.
GASTRO CON: As these biologics come off-patent, what challenges will specialists face?
AC: I think the one challenge—and where we lack data in IBD specifically—is with multiple switches between various biosimilars and the reference product. For example, a patient is started on the branded or innovator infliximab, and their insurance forces a switch to a biosimilar—call it biosimilar A. Two years later, their insurance company gets a better deal from biosimilar B and forces another switch, and 2 years after that, the branded one now becomes the preferred agent. Currently in IBD we do not have safety data on multiple switches. No interchangeable biosimilars have been approved for use in the United States by the FDA. There have been 2 studies of psoriasis where they did multiple medication switches, 1 study was with adalimumab and the other with etanercept (which we do not use for IBD). In these, efficacy and safety of multiple switches were similar.
