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Biosimilars approved in Europe Posted 08/07/2011

Last update: 14 November 2014 

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then EMA has developed many general and specific guidelines for biosimilars [1].

Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 [2]. To date, EMA has approved 22 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoietin, insulin and TNF-inhibitor, for use in the EU, see Table 1. Two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving a total of 20 biosimilars approved for use in Europe.

Table 1: EMA approved biosimilars*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/Company name

Abasria

insulin
glargine

Diabetes

9 Sep 2014

Eli Lilly/Boehringer
Ingelheim

Abseamed

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

28 Aug 2007

Medice Arzneimittel Pütter

Accofil

filgrastim

Neutropenia

18 Sep 2014

Accord Healthcare

Bemfola

follitropin alfa

Anovulation (IVF)

24 March 2014

Finox Biotech

Binocrit

epoetin alfa

Anaemia
Chronic kidney failure

28 Aug 2007

Sandoz

Biograstim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

CT Arzneimittel

Epoetin alfa Hexal

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

28 Aug 2007

Hexal

Filgrastim Hexal

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

6 Feb 2009

Hexal

Filgrastim ratiopharm

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008
Withdrawn on 20 Apr 2011 

Ratiopharm

Grastofil

filgrastim

Neutropenia

18 Oct 2013

Apotex

Inflectra

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

10 Sep 2013

Hospira

Nivestim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

8 Jun 2010

Hospira

Omnitrope

somatropin

Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome

12 Apr 2006

Sandoz

Ovaleap

follitropin alfa

Anovulation (IVF)

27 Sep 2013

Teva Pharma

Ratiograstim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

Ratiopharm

Remsima

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

10 Sep 2013

Celltrion

Retacrit

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

Hospira

Silapo

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

STADA R & D

Somatropin Biopartners

somatropin

Growth hormone deficiency

5 Aug 2013

BioPartners

Tevagrastim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

Teva Generics

Valtropin

somatropin

Pituitary dwarfism
Turner syndrome

24 Apr 2006
Withdrawn on 10 May 2012 

BioPartners

Zarzio

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

6 Feb 2009

Sandoz

*Data collected on 12 May 2011, updated on 14 November 2014
IVF: in vitro fertilization.
Source: EMA

The positive opinion reached by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 27 June 2013 for the inflximab biosimilars Inflectra and Remsima was a landmark decision, proving that the biosimilar concept can be successfully applied to such complex molecules as monoclonal antibodies.

The positive opinion reached by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 26 July 2014 for the insulin glargine biosimilar comes as a relief to diabetes sufferers in Europe, after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel LifeSciences in November 2012 [3].

Related articles

Biosimilars applications under review by EMA – 2013 Q4

Remsima approved in Colombia

EMA approves first monoclonal antibody biosimilar

Biosimilar monoclonal antibody approved in Korea

References

1.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe

3. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications

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Source: EMA

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