OMLYCLO
GrowthmAbBLAINJECTIONINJECTABLE
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
2/8 — Basic
Drug data last refreshed 9h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMLYCLO is a monoclonal antibody (mAb) therapeutic approved by the FDA on March 7, 2025, developed by Celltrion. The mechanism of action and specific indication are currently undisclosed. This product represents Celltrion's expansion into the biologic therapeutics space via BLA approval.
Growth
Early-stage mAb in growth phase with moderate competitive pressure (30/100); small or newly established commercial team expected to scale rapidly.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Started Oct 2025
225 enrolled
Chronic Spontaneous Urticaria (CSU)Allergic Asthma
Career Relevance
OMLYCLO represents a ground-floor opportunity with a newly approved injectable mAb at Celltrion, a growing biologics company. Career growth potential is high if the product achieves market traction, but current lack of indication clarity and linked job postings suggests the commercial infrastructure is still being built.
Brand Manager
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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.