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Biosimilars approved in Europe Posted 08/07/2011

Last update: 26 May 2017

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 38 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoesis stimulating agent, insulin, follicle-stimulating hormone (FSH), parathyroid hormone and tumour necrosis factor (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 Two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving a total of 36 biosimilars approved for use in Europe.

Table 1: EMA approved biosimilars*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/Company name

Abasaglar (previously 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

Amgevita

adalimumab

Crohn’s disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Spondylarthritis
Suppurativa hidradenitis
Ulcerative colitis
Uveitis

22 Mar 2017 

Amgen

Benepali

etanercept

Axial spondyloarthritis
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis 

14 Jan 2016

Samsung Bioepis

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

Blitzima

rituximab

Non-Hodgkin lymphoma
Chronic B-cell lymphocytic leukaemia

CHMP positive opinion on 18 May 2017

Celltrion

Epoetin alfa Hexal

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

28 Aug 2007

Hexal

Erelzi

etanercept

Ankylosing spondylitis
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis

CHMP positive opinion on 21 April 2017

Sandoz

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

Flixabi

infliximab

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

26 May 2016

Samsung Bioepis

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

Inhixa

enoxaparin sodium

Venous thromboembolism

15 Sep 2016

Techdow Europe

Insulin lispro Sanofi

Insulin lispro

Diabetes mellitus

CHMP positive opinion on 18 May 2017

Sanofi-Aventis

Lusduna

insulin glargine

Diabetes

4 Jan 2017

Merck (MSD)

Movymia

teriparatide

Osteoporosis

11 Jan 2017

STADA Arzneimittel

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

Ritemvia

rituximab

Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma

   

Rixathon

rituximab

Chronic B-cell lymphocytic leukaemia
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis

CHMP positive opinion on 21 April 2017

Sandoz

Riximyo

rituximab

Chronic B-cell lymphocytic leukaemia
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis

CHMP positive opinion on 21 April 2017

Sandoz

Silapo

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

STADA R & D

Solymbic

adalimumab

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

CHMP positive opinion on 26 January 2017

Amgen

Terrosa

teriparatide

Osteoporosis

4 Jan 2017

Gedeon Richter

Tevagrastim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

Teva Generics

Thorinane

enoxaparin sodium

Venous thromboembolism

15 Sep 2016

Pharmathen

Truxima

rituximab

Chronic lymphocytic leukaemia
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin’s lymphoma
Rheumatoid arthritis

17 Feb 2017

Celltrion

Tuxella

rituximab

Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Chronic B-cell lymphocytic leukaemia

CHMP positive opinion on 18 May 2017

Celltrion

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 26 May 2017

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 infliximab 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 came 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
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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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