The FDA has approved ustekinumab-auub (Wezlana – Amgen), an interchangeable biosimilar product similar to the interleukin-12 and -23 antagonist Stelara, for treatment of the same indications as Stelara (see Table 1). Wezlana is the first Stelara biosimilar to be approved in the US.

The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

The injectable interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults; it was approved earlier for treatment of ulcerative colitis (UC), plaque psoriasis, and psoriatic arthritis. The IL-23 antagonists risankizumab (Skyrizi) and mirikizumab (Omvoh) and the IL-12/23 antagonist ustekinumab (Stelara, and biosimilars) are also approved for treatment of CD.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

The injectable interleukin (IL)-23 antagonist risankizumab-rzza (Skyrizi – Abbvie), previously approved by the FDA for treatment of Crohn's disease (CD), has now been approved for treatment of moderately to severely active ulcerative colitis (UC) in adults. Risankizumab is the first IL-23 antagonist to be approved for treatment of both CD and UC. It is also approved for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.