OMLYCLO
GrowthmAbBLAINJECTIONINJECTABLE
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
2/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMLYCLO is a monoclonal antibody (mAb) therapeutic developed by Celltrion, approved as a Biologics License Application (BLA) on March 7, 2025. The specific indication and mechanism of action are not yet publicly detailed in available sources. This is an injectable biologic in early commercial growth phase.
Growth
Early-stage launch with modest competitive pressure (30/100) suggests a focused commercial team building market awareness and establishing prescriber relationships.
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 growth-stage launch opportunity with a South Korean biotech sponsor expanding into Western markets. Career progression on this brand offers early-stage commercialization experience with moderate competitive intensity and long patent runway ahead.
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.