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 hospitalpharmacyeurope.com | 2019 | 19