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Biosimilars of somatropin

Biosimilars/General | Posted 01/04/2019 2 Post your comment

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 Withdrawn in May 2012 [2].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 Withdrawn in December 2017 [3]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

Comments (2)

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Posted 19/05/2023 by Anthika U, GaBI Online Editorial Office

Response to ‘Generics and Biosimilars’

Dear Mr Victor Perez Medina Martinez,
Thank you for your valuable comments received on 18 May 2023. We appreciate that you are letting us know, kindly continue with your valuable comments to GaBI Online.
Best Regards,
Anthika

Posted 18/05/2023 by Victor Perez Medina Martinez

Generics and Biosimilars

A decade ago, I remember that people ask me about quality of generics and after similars. Then their quality was questionable. By the years this guideline changed. Now that generics and similars are even better than originators. Their quality control and production is by most excellent.