Home/Biosimilar Atlas/Somatropin/Omnitrope

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 · Company profile
FDANot listed
EMAApr 2006authorised
MHRALicenseddate not shown
PMDAJun 2009approved
HCApr 2009approved
CDSCONot listed
EDEMay 2014registered
Approved or registered in 5 of 7 markets
Connections
SomatropinmoleculeSandozdeveloper5 of 7markets0trials behind it9other products, same developer0rival developers in its markets

About Omnitrope

Omnitrope is Sandoz's somatropin and the first biosimilar ever approved in the European Union, in April 2006. Japan approved it in 2009 as its first biosimilar, Canada the same year, and it is registered in the UAE. In the United States it was approved in 2006 through the drug route and is not counted as a biosimilar there. Twenty years on it remains the only somatropin biosimilar sold in Europe.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Omnitrope

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
First biosimilar authorised in the EU.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Omnitrope

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Omnitrope
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
5 mg, 10 mg and 15 mg cartridges
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan · Somatropin BS [Sandoz]

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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)
Remarks
The first biosimilar approved in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada · Omnitrope

Health CanadaApproved
Brand
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 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Omnitrope

Emirates Drug EstablishmentRegistered
Brand
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 (UAE Emirates Drug Establishment) · checked Sep 2026

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Erelzi, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.

Chronology

Sources

All somatropin biosimilars

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Data current to September 2026.