Omnitrope
Somatropin biosimilar developed by Sandoz. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Omnitrope (EU, UAE); Omnitrope (USA, approved under 505(b)(2), not a 351(k) biosimilar) · Commercial partner or holder: Sandoz
FDAnot listed
EMAApr 2006authorised
PMDAJun 2009approved
HCApr 2009approved
CDSCOnot listed
EDEMay 2014registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Omnitrope
European Medicines Agency and European CommissionApprovedBrand
Omnitrope
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Apr 2006
Application or permission
EMEA/H/C/000607
Indications as licensed
Growth disturbance in children; growth hormone deficiency in adults
Presentations
see SmPC
Note
First biosimilar authorised in the EU.
Source
S017
PMDA
Japan · Somatropin BS [Sandoz]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Somatropin BS [Sandoz]
Holder or applicant
Sandoz K.K.
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jun 2009
Indications as licensed
Growth hormone deficiency, Turner syndrome, chronic renal insufficiency in children
Presentations
5 mg and 10 mg; SurePal pens (2015)
Note
The first biosimilar approved in Japan.
Source
S020
HC
Canada · Omnitrope
Health CanadaApprovedBrand
Omnitrope
Holder or applicant
Sandoz Canada Incorporated
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2009
Application or permission
DIN 02325055, 02325063, 02325071, 02459647
Presentations
10, 15, 5, 5.8 mg
Source
S022
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Omnitrope
Emirates Drug EstablishmentRegisteredBrand
Omnitrope
Holder or applicant
Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
May 2014
Presentations
5 mg/1.5 mL, 10 mg/1.5 mL
Source
S018
Chronology
- EMAApr 2006Authorised by the European Commission as Omnitrope
- HCApr 2009Notice of Compliance, Health Canada as Omnitrope
- PMDAJun 2009Approved by MHLW as Somatropin BS [Sandoz]
- EDEMay 2014Registered in the UAE as Omnitrope
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
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