Recent years witnessed a surge in Inflammatory Bowel Disease (IBD) biologics, notably since AbbVie’s Humira gained FDA approval in 2007 for moderate-severe Crohn’s disease (CD). Seven biologics entered the IBD market thereafter, but with more //anticipated entries, GlobalData suggests potential forces that could impede previous growth.

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, highlights barriers to US growth, particularly patent expirations leading to biosimilar entries and mounting support for drug price regulations.

Inflammatory Bowel Disease (IBD) encompasses chronic inflammatory conditions like Crohn’s disease and ulcerative colitis, impacting the digestive tract and causing symptoms ranging from abdominal pain to severe diarrhea. These conditions result from the body’s immune response against its gastrointestinal system, leading to long-term inflammation and damage.

PhRMA’s Diminished Clout in the US Amid Departures and Regulatory Signals

In the US, pharmaceutical lobbying groups like PhRMA face reduced influence due to member departures like AstraZeneca, AbbVie, and Teva, hinting at broader backing for regulations. However, these challenges might not affect the EU and established markets with low drug pricing regulations.

Badejo underscores emerging small molecules like JAK and S1PR as competitors to biologics due to their oral administration and lower costs. Their comparable efficacy could challenge biologics’ market dominance, intensified by the advent of their generics. He notes AbbVie’s approach, offering both a biologic (Skyrizi) and a small molecule (Rinvoq), poised to shape the market significantly.

Source-Medindia