Somatropin biosimilars
Growth hormone for children who do not grow and adults who lack it, and the molecule of Omnitrope, the first biosimilar ever approved in Europe.
About somatropin
Somatropin is manufactured human growth hormone, identical to the hormone the pituitary gland makes. It is used for children whose growth has stalled and for adults with a hormone deficiency.
It acts on the growth hormone receptor and, through a second hormone made by the liver, drives growth at the ends of bones in children and maintains muscle, fat and bone in adults.
A daily injection under the skin from a pen, with the dose set by weight. Newer once-weekly forms of the original hormone are new medicines, not biosimilars.
Growth failure in children from several causes, and growth hormone deficiency in adults.
A biosimilar is compared in the laboratory, in healthy volunteers by measuring the liver hormone it stimulates, and in a clinical study of growth rate in children over six to twelve months.
The reference product for Omnitrope is Genotropin, from Pfizer. Several originator brands compete, all approved country by country in Europe before central approval existed, so none has a European product number.
Somatropin was the first biosimilar in European law, in 2006, and it remains a small market for them: one European product twenty years on, and none in the United States under the biosimilar pathway. In India the picture is reversed, with a dozen importers and two domestic makers.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todaysix somatropin biosimilars are approved in at least one of the seven markets.
- AheadNo further candidate is visible in comparative trials or under review, so the competitive set is the approved products in the register below.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| EMA | Omnitrope | Sandoz GmbH | Apr 2006 | EMEA/H/C/000607 | Approved | S017 | |
| EMA | Valtropin | BioPartners GmbH | Apr 2006 | EMEA/H/C/000602 | Withdrawn | S017 | |
| MHRA | Omnitrope | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Somatropin BS [Sandoz] | Sandoz K.K. | Jun 2009 | not published | Approved | S020 | |
| HC | Omnitrope | Sandoz Canada Incorporated | Apr 2009 | DIN 02325055, 02325063, 02325071, 02459647 | Approved | S022 | |
| CDSCO | L.G. Chemicals (LG Life Sciences) (INN only) | L.G. Chemicals (LG Life Sciences) | Aug 2002 | Import permission | Approved | S013 | |
| CDSCO | SciGen Biopharma (INN only) | SciGen Biopharma Pvt Ltd | Jun 2010 | Import permission | Approved | S013 | |
| CDSCO | USV (INN only) | USV Limited | Jun 2013 | MF-112/2013 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | May 2018 | MF-145/2018 | Approved | S014 | |
| CDSCO | Cipla (INN only) | Cipla Limited | Oct 2020 | IMP/BIO/20/000082 (additional marketing authorisation) | Approved | S012 | |
| EDE | Omnitrope | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | May 2014 | not published | Registered | S018 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for a somatropin biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k), open since 23 March 2020 when somatropin NDAs became biologics licences; Omnitrope (2006) predates it and was approved under 505(b)(2), so no somatropin has been approved as a 351(k) biosimilar | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for somatropin programmes. Regulatory strategy consulting
Presentations and concentration
Cartridges and pens of 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL; lyophilised vials of 1.33 mg (4 IU) to 12 mg (36 IU) in India.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Omnitrope | · | see SmPC | 5 mg, 10 mg and 15 mg cartridges | 5 mg and 10 mg; SurePal pens (2015) | 10, 15, 5, 5.8 mg | · | 5 mg/1.5 mL, 10 mg/1.5 mL |
| Valtropin | · | see SmPC | · | · | · | · | · |
| USV somatropin | · | · | · | · | · | Injection | · |
| Reliance Life Sciences somatropin | · | · | · | · | · | Injection | · |
| LG Life Sciences somatropin | · | · | · | · | · | 4 IU vial; sustained-release vial (2013) | · |
| SciGen somatropin | · | · | · | · | · | Powder and solution for injection | · |
| Cipla somatropin | · | · | · | · | · | 4 IU vial with solvent | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Sandoz | Omnitrope | · | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| BioPartners (LG Life Sciences) | Valtropin | · | withdrawn | · | · | · | · | · |
| USV | USV somatropin | · | · | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences somatropin | · | · | · | · | · | ✓ | · |
| LG Life Sciences | LG Life Sciences somatropin | · | · | · | · | · | ✓ | · |
| SciGen | SciGen somatropin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Cipla somatropin | · | · | · | · | · | ✓ | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Omnitrope
Valtropin
USV somatropin
Reliance Life Sciences somatropin
LG Life Sciences somatropin
SciGen somatropin
Cipla somatropin
In development
No comparative trial of a somatropin biosimilar candidate against the reference product was found on ClinicalTrials.gov with the word biosimilar in the record. That does not mean nothing is in development: programmes registered only on national registries, or under a code without the word, are not captured. See the pipeline page for how the list is built.
Questions
Why is Omnitrope not a biosimilar in the United States?
It was approved there in 2006 through the drug route, long before somatropin became a biologic in 2020. It is licensed as a biologic today but was never assessed as a biosimilar.
Which was the first biosimilar in Europe?
Omnitrope, Sandoz's somatropin, in April 2006.
Is there a somatropin biosimilar in India?
USV and Reliance hold manufacturing permissions, and several companies import products from Korea, Australia and elsewhere.
Which somatropin biosimilars are registered in the UAE?
Omnitrope, alongside Genotropin, Norditropin and Saizen.
Why do the originator products have no European product number?
They were approved in each European country separately before the central system covered them.
How is a somatropin biosimilar tested?
Laboratory comparison, a volunteer study measuring the liver hormone it stimulates, and a clinical study of growth rate in children.
Work with EvySaif on somatropin
Somatropin biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for somatropin, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) 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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)
Planning somatropin biosimilar development?
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