Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.
Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, emphasized that although adalimumab biosimilars are new to gastroenterologists, this is not their first experience with anti–tumor necrosis factor (TNF) agents.
Hanauer helped run an analysis that demonstrated the safety and efficacy of an adalimumab biosimilar (Cyltezo) in patients with advanced Crohn disease. As of October 2023, it is the only study assessing an adalimumab biosimilar in patients with inflammatory bowel disease, which is an umbrella term for Crohn disease and ulcerative colitis.
Transcript
With 8 adalimumab biosimilars now on the US market, how are gastroenterologists reacting to these new products and are there concerns about extrapolated indications for inflammatory bowel disease?
The 8 adalimumab biosimilars are not gastroenterologists' first experience with biosimilars actually. We've had some experience with infliximab biosimilars over the past several years. In reality, it's unlikely that most gastroenterologists are going to prescribe a specific biosimilar because they're so much dependent on third party payers and their individual preferences. So, I think it's more likely that gastroenterologists are going to order for instance, Humira [reference adalimumab] and accepted alternative biosimilar or use the term "adalimumab" and again, accept biosimilars.
How important is it to have trials for adalimumab products and other anti-TNF biosimilars tested in patients with gastroenterology conditions, especially when most of the other trials for these products have only been tested in rheumatoid arthritis and psoriatic arthritis populations?
Again, gastroenterologists, overall have accepted the regulations for biosimilars that allow for extrapolation. However, having individual studies with specific biosimilars do provide a little bit more reassurance, perhaps, that the performance is going to be as [similar to the reference product] as anticipated.
Patients With IBD Maintain Therapy 2 Years Post-Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Comparable Pregnancy and Infant Milestones With Infliximab Biosimilars vs Originator in IBD
March 15th 2025A study evaluating pregnancy outcomes and infant developmental milestones found similar outcomes between pregnant women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.