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.
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.