The FDA has approved several biosimilars for inflammatory bowel disease (IBD), including multiple alternatives for Stelara (ustekinumab) and Humira (adalimumab), with launches set for early 2025. These approvals aim to improve patient access, reduce healthcare costs, and expand treatment options for Crohn’s disease and ulcerative colitis.
Key approvals include:
- Stelara Biosimilars: Selarsdi, Yesintek, Imuldosa, Otulfi, and Pyzchiva, offering subcutaneous and IV formulations for IBD and other inflammatory conditions.
- Humira Biosimilars: Simlandi and Cyltezo, featuring high-concentration, citrate-free options for multiple inflammatory diseases.