HPE HPE Fresenius Kabi handbook | Page 20

TABLE 1
Authorised biosimilars (to October 2018) (Continued)
Product name INN/active substance Therapeutic area Marketing authorisation
holder Marketing authorisation
date
Flixabi Infliximab Rheumatoid arthritis,
psoriatic arthritis,
ulcerative colitis, Crohn’s
disease, ankylosing
spondylitis Samsung Bioepis UK
Limited 26/5/2016
Inhixa Enoxaparin sodium Venous thromboembolism Techdow Europe AB 15/9/2016
Thorinane Enoxaparin sodium Venous thromboembolism Pharmathen SA 15/9/2016
Lusduna Insulin glargine Diabetes MSD 04/01/2017
Terrosa Teriparatide Osteoporosis Gedeon Richter 04/01/2017
Movymia Teriparatide Osteoporosis Stada Arzneimittel 11/01/2017
Truxima Rituximab Chronic lymphocytic
leukaemia,
granulomatosis with
polyangiitis, microscopic
polyangiitis, non-
Hodgkin’s lymphoma,
rheumatoid arthritis Celltrion 17/02/2017
Amgevita Adalimumab Ankylosing spondylitis,
Crohn’s disease, juvenile
rheumatoid arthritis,
psoriasis, psoriatic
arthritis, rheumatoid
arthritis, ulcerative colitis Amgen 22/03/2017
Solymbic Adalimumab Ankylosing spondylitis,
Crohn’s disease,
hidradenitis suppurativa,
psoriasis, psoriatic
arthritis, rheumatoid
arthritis, ulcerative colitis Amgen 22/03/2017
Flixabi Infliximab Ankylosing spondylitis,
Crohn’s disease, psoriatic
arthritis, psoriasis,
rheumatoid arthritis,
ulcerative colitis Samsung Bioepis 26/05/2017
Riximyo Rituximab Chronic B-cell
lymphocytic leukaemia,
microscopic polyangiitis,
non-Hodgkin lymphoma,
rheumatoid arthritis,
Wegener granulomatosis Sandoz 15/06/2017
Rixathon Rituxumab Chronic B-cell
lymphocytic leukaemia,
microscopic polyangiitis,
non-Hodgkin lymphoma,
rheumatoid arthritis,
Wegener granulomatosis Sandoz 19/06/2017
Erelzi Etanercept Ankylosing spondylitis,
juvenile rheumatoid
arthritis, psoriasis,
psoriatic arthritis,
rheumatoid arthritis Sandoz 23/06/2017
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