HPE Biosimilars: Where are we and what is next? - Page 7

Product name
INN / active substance
Therapeutic area
Marketing authorisation
holder
Marketing authorisation date
Blitzima
Rituximab
Non-Hodgkin lymphoma , chronic B-cell lymphocytic leukaemia
Celltrion
13 / 07 / 2017
Ritemvia
Rituxumab
Wegener granulomatosis , microscopic polyangiitis , non-Hodgkin lymphoma
Celltrion
13 / 07 / 2017
Rituzena ( previously Tuxella )
Rituxumab
Wegener granulomatosis , microscopic polyangiitism non-Hodgkin lymphoma , chronic B-cell lymphocytic leukaemia
Celltrion
13 / 07 / 2017
Insulin lispro Sanofi
Insulin lispro
Diabetes mellitus
Sanofi Aventis
19 / 07 / 2017
Imraldi
Adalimumab
Ankylosing spondylitis , arthritis , Crohn ’ s disease , hidradenitis suppurativa , psoriatic arthritis , psoriasis , rheumatoid arthritis , ulcerative colitis , uveitis
Samsung Bioepis
24 / 08 / 2017
Cyltezo
Adalimumab
Crohn ’ s disease , hidradenitis suppurativa , juvenile idiopathic arthritis , psoriasis , psoriatic arthritis , rheumatoid arthritis , ulcerative colitis , uveitis
Boehringer Ingelheim
10 / 11 / 2017
Ontruzant
Trastuzumab
Early breast cancer , metastatic breast cancer , metastatic gastric cancer
Samsung Bioepis
15 / 11 / 2017
Mvasi
Bevacizumab
Breast neoplasms , fallopian tube neoplasms , non-small-cell lung carcinoma , ovarian neoplasms , peritoneal neoplasms , renal cell carcinoma
Amgen
15 / 01 / 2018
Herzuma
Trastuzumab
Early breast cancer , metastatic breast cancer , metastatic gastric cancer
Celltrion Healthcare
09 / 02 / 2018
Semglee
Insulin glargine
Diabetes mellitus
Mylan
28 / 03 / 2018
Kanjinti
Trastuzumab
Early breast cancer , metastatic breast cancer , metastatic gastric cancer
Amgen
16 / 05 / 2018
Zessly
Infliximab
Ankylosing spondylitis , Crohn ’ s disease , psoriatic arthritis , psoriasis , rheumatoid arthritis , ulcerative colitis
Sandoz
18 / 05 / 2018
Halimatoz
Adalimumab
Ankylosing spondylitis , hidradenitis suppurativa , juvenile rheumatoid arthritis , psoriatic arthritis , psoriasis , rheumatoid arthritis , uveitis
Sandoz
26 / 07 / 2018
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