Imuldosa Approved as Stelara^® Biosimilar

The FDA recently approved Imuldosa (ustekinumab-srlf) injections as a biosimilar to Stelara. This drug is indicated for the treatment of:

• Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Active psoriatic arthritis
• Moderately to severely active Crohn’s disease
• Moderately to severely active ulcerative colitis

Dosage varies by weight, age, and indication, with follow-up injections given at different intervals for each indication.

Adverse reactions also vary by indication:

• Those with psoriasis could experience upper respiratory tract infection, headache, and fatigue 
• Those with Crohn’s disease could experience induction, vomiting, injection site erythema, bronchitis, pruritus, urinary tract infection, and sinusitis
• Those with ulcerative colitis could experience induction, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea

Imuldosa should not be used in patients with active infections, tuberculosis, malignancies, hypersensitivity, and noninfectious pneumonia.

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