HPE HPE Fresenius Kabi handbook | Page 19

TABLE 1
Authorised biosimilars (to October 2018)
Product name INN/active substance Therapeutic area Marketing authorisation
holder Marketing authorisation
date
Omnitrope Somatropin Dwarfism, Prader-
Willi syndrome, Turner
syndrome Sandoz 12/4/2006
Abseamed Epoetin alfa Chronic kidney failure Medice 28/8/2007
Binocrit Epoetin alfa Chronic kidney failure,
anaemia Sandoz 28/8/2007
Epoetin alfa Hexal Epoetin alfa Chronic kidney failure,
anaemia Hexal 28/8/2007
Retacrit Epoetin zeta Anaemia, autologous
blood transfusion, chronic
kidney failure Hospira 18/12/2007
Silapo Epoetin zeta Anaemia, autologous
blood transfusion, chronic
kidney failure Stada 18/12/2007
Ratiograstim Filgrastim Cancer, haematopoietic
stem cell transplantation,
neutropenia Ratiopharm 15/9/2008
Tevagrastim Filgrastim Cancer, haematopoietic
stem cell transplantation,
neutropenia Teva Generics 15/9/2008
Zarzio Filgrastim Cancer, haematopoietic
stem cell transplantation,
neutropenia Sandoz 6/2/2009
Filgrastim Hexal Filgrastim Cancer, haematopoietic
stem cell transplantation,
neutropenia Hexal 6/2/2009
Nivestim Filgrastim Cancer, haematopoietic
stem cell transplantation,
neutropenia Hospira UK 8/6/2010
Inflectra Infliximab Rheumatoid arthritis,
psoriatic arthritis,
ulcerative colitis, Crohn’s
disease, ankylosing
spondylitis Hospira UK 10/9/2013
Remsima Infliximab Rheumatoid arthritis,
psoriatic arthritis,
ulcerative colitis, Crohn’s
disease, ankylosing
spondylitis Celltrion Healthcare
Hungary 10/9/2013
Ovaleap Follitropin alfa Anovulation Teva Pharma 27/9/2013
Grastofil Filgrastim Neutropenia Apotex Europe 18/10/2013
Bemfola Follitropin alfa Anovulation Finox Biotech 27/3/2014
Accofil Filgrastim Neutropenia Accord Healthcare 18/9/2014
Abasaglar Insulin glargine Diabetes Eli Lilly Regional
Operations 9/9/2014
Benepali Etanercept Rheumatoid arthritis,
psoriatic arthritis,
psoriasis Samsung Bioepis UK 14/1/2016
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