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Biosimilars of somatropin Posted 01/04/2019

Somatropin or human growth hormone (hGH) is a peptide hormone that stimulates growth, cell reproduction and cell regeneration in humans and other animals. It is thus important in human development. It is a type of mitogen which is specific only to certain kinds of cells. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.

The originator product, Ipsen Pharma’s NutropinAq/Eli Lilly’s Humatrope (somatropin), was approved by the US Food and Drug Administration in October 1986 and by the European Medicines Agency in February 2001 [1].

The patents on NutropinAq/Humatrope expired in both Europe and in the US [1]. Some of the somatropin biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of somatropin approved or in development

Company name, Country

Product name

Stage of development

Amega Biotech, Argentina*

-

Investigation into growth disorders in Argentina ongoing August 2013

 

 

 

BioPartners, Switzerland/Poland

Valtropin/ Somatropin

Valtropin approved in the EU in April 2006. Withdrawn in May 2012 [2]. Somatropin Biopartners approved in the EU in September 2013. Withdrawn in December 2017 [3]

Biosidus, Argentina*

HHT

‘Medicamento biológico similar’approved in Argentina

Ferring Pharmaceuticals, Switzerland

Zomacton

‘Similar biologic’ approved in India in April 2010 [4]

LG Life Sciences, India*

Eutropin

‘Similar biologic’ approved in India in December 2013 [4]

Sandoz, USA

Omnitrope

Approved by EU in April 2006 [5]

USV, India*

Somatropin

‘Similar biologic’ approved in India [4]

EU: European Union.

*See editor’s comment

Sandoz’s Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 [5].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘medicamento biológico similares’ approved in Argentina might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar follitropin alfa and somatropin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-follitropin-alfa-and-somatropin 
4. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe

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Source: Source: EMA

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