USV somatropin
Somatropin biosimilar developed by USV. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
About USV somatropin
USV received the first Indian permission for a domestically made somatropin, in June 2013, for children with growth hormone deficiency. Earlier Indian supply had come through imports.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where USV somatropin holds an approval, these are the other somatropin biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | LG Chem (LG Life Sciences somatropin), Not stated in the CDSCO list (Cipla somatropin), Reliance Life Sciences (Reliance Life Sciences somatropin), SciGen (SciGen somatropin) |
Same developer, other molecules
Other biosimilars in the Atlas developed by USV: USV pegfilgrastim, USV teriparatide.
Chronology
- CDSCOJun 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning somatropin biosimilar development?
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