Reliance Life Sciences somatropin
Somatropin biosimilar developed by Reliance Life Sciences. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
About Reliance Life Sciences somatropin
Reliance Life Sciences received its somatropin permission in India in May 2018, for growth failure in children and hormone deficiency in adults, the second domestic maker after USV.
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 Reliance Life Sciences 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), SciGen (SciGen somatropin), USV (USV somatropin) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Reliance Life Sciences: Reliance Life Sciences adalimumab, Reliance Life Sciences bevacizumab, Reliance Life Sciences darbepoetin alfa, Reliance Life Sciences denosumab, Reliance Life Sciences etanercept, Reliance Life Sciences follitropin alfa, Reliance Life Sciences golimumab, Reliance Life Sciences infliximab, Reliance Life Sciences omalizumab, Reliance Life Sciences ranibizumab, Reliance Life Sciences rituximab, Reliance Life Sciences trastuzumab, UstekiRel.
Chronology
- CDSCOMay 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning somatropin biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultant