BLASUBCUTANEOUSINJECTION, SOLUTION
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Otulfi (ustekinumab-aauz) by Fresenius Kabi is interleukin-12 antagonists [moa]. First approved in 2025.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Otulfi (ustekinumab-aauz) is a monoclonal antibody antagonist of interleukin-12, a key cytokine in immune-mediated inflammatory diseases. This subcutaneous injection was approved by the FDA on September 29, 2025, as a biosimilar referencing the innovator ustekinumab (Stelara). It represents Fresenius Kabi's entry into the IL-12 antagonist market.
Launch
As a newly launched biosimilar with moderate competitive pressure (30%), early-stage commercial teams will focus on payer access and market penetration in an established therapeutic class.
Mechanism of Action
Interleukin-12 Antagonists
Pharmacologic Class:
Interleukin-12 Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Otulfi is a newly launched biosimilar with moderate competitive pressure, creating focused career opportunities in commercial execution, payer strategy, and market access. Early hires on the Otulfi team will shape its competitive positioning and brand trajectory in a crowded IL-12 antagonist market.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.