HPE Biosimilars: Where are we and what is next? - Page 6

TABLE 1
Authorised biosimilars ( to June 2019 ) ( 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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