STUDI ED ANALISI

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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

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

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 Mar 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 
Withdrawn on 22 Dec 2016

CT Arzneimittel

Blitzima

rituximab

Non-Hodgkin lymphoma
Chronic B-cell lymphocytic leukaemia

13 Jul 2017

Celltrion

Cyltezo

adalimumab

Crohn’s disease
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Uveitis

10 Nov 2017

Boehringer Ingelheim

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

27 Jun 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Withdrawn on 20 Apr 2011 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

Halimatoz

adalimumab

Ankylosing spondylitis
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Uveitis

CHMP positive opinion 1 Jun 2018

Sandoz

Hefiya

adalimumab

Ankylosing spondylitis
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Psoriasis
Uveitis

CHMP positive opinion 1 Jun 2018

Sandoz

Hulio

adalimumab

Ankylosing spondylitis
Crohn’s Disease
Hidradenitis suppurativa
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative Colitis
Uveitis

CHMP positive opinion 26 Jul 2018

Mylan/Fujifilm Kyowa Kirin Biologics

Hyrimoz

adalimumab

Ankylosing spondylitis
Crohn’s Disease
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Papulosquamous skin disease
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative Colitis
Uveitis

CHMP positive opinion 1 Jun 2018

Sandoz

Herzuma

trastuzumab

Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer

14 Feb 2018

Celltrion Healthcare

Imraldi

adalimumab

Ankylosing spondylitis
Arthritis
Crohn’s Disease
Hidradenitis suppurativa
Psoriatic arthritis,
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis

24 Aug 2017

Samsung Bioepis

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

19 Jul 2017

Sanofi-Aventis

Kanjinti

trastuzumab

Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer

CHMP positive opinion 28 Mar 2018

Amgen/Allergan

Lusduna

insulin glargine

Diabetes

4 Jan 2017

Merck (MSD)

Movymia

teriparatide

Osteoporosis

11 Jan 2017

Stada Arzneimittel

Mvasi

bevacizumab

Breast neoplasms Fallopian tube neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma

15 Jan 2018

Amgen

Nivestim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

8 Jun 2010

Hospira (Pfizer)

Omnitrope

somatropin

Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome

12 Apr 2006

Sandoz

Ontruzant

trastuzumab

Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer

15 Nov 2017

Samsung Bioepis

Ovaleap

follitropin alfa

Anovulation (IVF)

27 Sep 2013

Teva Pharma

Pelgraz

pegfilgrastim

Neutropenia

CHMP positive opinion 26 Jul 2018

Accord Healthcare

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

13 Jul 2017

Celltrion

Rituzena (previously Tuxella)

rituximab

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

13 Jul 2017

Celltrion

Rixathon

rituximab

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

19 Jun 2017

Sandoz

Riximyo

rituximab

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

15 Jun 2017

Sandoz

Semglee

insulin glargine

Diabetes

28 Mar 2018

Mylan

Silapo

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

Stada Arzneimittel

Solymbic

adalimumab

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

22 Mar 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

Trazimera

trastuzumab

Stomach Neoplasms
Breast Neoplasms

CHMP positive opinion 1 Jun 2018

Pfizer

Truxima

rituximab

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

17 Feb 2017

Celltrion

Udenyca

pegfilgrastim

neutropenia

CHMP positive opinion 26 Jul 2018

ERA Consulting 

Valtropin

somatropin

Pituitary dwarfism
Turner syndrome

24 Apr 2006
Withdrawn on 10 May 2012 

BioPartners

Zessly

infliximab

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

24 May 2018

Sandoz

Zarzio

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

6 Feb 2009

Sandoz

*Data collected on 12 May 2011, updated on 24 August 2018
CHMP: Committee for Medicinal Products for Human Use; VF: in vitro fertilization.
Source: EMA