HPE Biosimilars: Where are we and what is next? - Page 8

TABLE 1
Authorised biosimilars ( to June 2019 ) ( continued )
Product name
INN / active substance
Therapeutic area
Marketing authorisation
holder
Marketing authorisation date
Hefiya
Adalimumab
Ankylosing spondylitis , hidradenitis suppurativa , juvenile rheumatoid arthritis , psoriasis , uveitis
Sandoz
26 / 07 / 2018
Hyrimoz
Adalimumab
Ankylosing spondylitis , Crohn ’ s disease , hidradenitis suppurativa , juvenile rheumatoid arthritis , papulosquamous skin disease , psoriatic arthritis , rheumatoid arthritis , ulcerative colitis , uveitis
Sandoz
26 / 07 / 2018
Trazimera
Trastuzumab
Breast neoplasm , stomach neoplasm
Pfizer
26 / 07 / 2018
Hulio
Adalimumab
Ankylosing spondylitis , Crohn ’ s disease , hidradenitis suppurativa , psoriasis , psoriatic arthritis , rheumatoid arthritis , ulcerative colitis , uveitis
Mylan / Fujifilm Kyowa Kirin Biologics
16 / 09 / 2018
Pelgraz
Pegfilgrastim
Neutropenia
Accord Healthcare
21 / 09 / 2018
Udenyca
Pegfilgrastrim
Neutropenia
ERA Consulting
20 / 09 / 2018
Ziextenzo
Pegfilgrastrim
Neutropenia
Sandoz
22 / 11 / 2018
Pelmeg
Pegfilgrastrim
Neutropenia
Cinfa Biotech
20 / 11 / 2018
Fulphila
Pegfilgrastrim
Neutropenia
Mylan
20 / 11 / 2018
Ogivri
Trastuzumab
Breast neoplasm , stomach neoplasm
Mylan
12 / 12 / 2018
Zirabev
Bevacizumab
Breast neoplasm , colorectal neoplasm , non-small-cell lung carcinoma , renal cell carcinoma , uterine cervical neoplasms
Pfizer Europe
12 / 02 / 2019
Idacio
Adalimumab
Ankylosing spondylitis , Crohn ’ s disease , hidradenitis suppurativa , juvenile rheumatoid arthritis , psoriasis , psoriatic arthritis , rheumatoid arthritis , ulcerative colitis , uveitis
Fresenius Kabi Deutschland GmbH
02 / 04 / 2019
Grasutek
Pegfilgrastim
Neutropenia
Juta Pharma GmbH
CHMP positive opinion 20 / 06 / 2019
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