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Indication and Side effect of Biosimilar

Market

Biosimila
r

16

US, EU,
Japan,
Australia,
New
Zealand

Filgrasti
m

EU, Japan,
Australia, ,
New
Zealand

Somatro
pin

EU, New
Zealand

EPO-alfa

EU

EPO-zeta

Indication
Febrile
neutropenia
Harvesting of
peripheral blood
stem cells
Neutropenic
disorder
Radiation injury
of bone marrow
Cachexia
associated with
AIDS
Growth hormone
deficiency
Short bowel
syndrome
Anemia
Surgical
procedure Transfusion of
blood product
Anemia
Surgical
procedure, Major
elective
orthopedic
surgery

ADR

Alopecia,Rash,Diar
hea, Anemia,
Bone
pain,Headache,
Cough, Fatigue,
Fever

Peripheral edema,
Injection site
reaction,
Gynecomastia,
Arthralgia,
Arthritis, Myalgia,
Headache
Edema, Injection
site irritation,
Nausea, Vomiting,
Arthralgia,
Myalgia, Cough
Aneurysm, Arteria
thrombosis,
Arteriovenous
shunt thrombosis
, Deep venous
thrombosis,
Hypertension,
Hypertensive
crisis, MI,
Myocardial
ischemia

Japan

EPOkappa
Inflixima
b

EU

Follitropi
n-alfa

EU, Japan,

Insulin
glargine

India, Korea,

Trastuzu
mab

India,

Adalimu
mab

EU, Japan,
Canada,
India, Korea

Rash, Abdominal
pain, Nausea,
Headache,
Pharyngitis,
Respiratory tract
infection, Fatigue,
Fever
Acne, Injection site
reaction,
Gynecomastia, LH
level abnormal,
Abdominal pain,
Nausea,
Thromboembolic
disorder, Abnorma
vaginal bleeding,
Multiple pregnancy
Diabetes mellitus Injection site pain,
Pruritus, Rash,
Hypoglycemia,
Lipodystrophy,
Nocturnal
hypoglycemia
Edema,
Breast cancer
Tachycardia, Rash,
Gastric cancer
Weight decreased,
Abdominal pain,
Diarrhea, Anemia,
Neutropenia,
Infectious disease,
Arthralgia, Cough
Injection site pain,
Ankylosing
Antibody
spondylitis
development,
Crohn's disease
Psoriatic arthritis Headache,
Ankylosing
spondylitis
Crohn's disease
Psoriatic arthritis
Rheumatoid
arthritis
Ulcerative colitis
Female infertility
Hypogonadotropi
c hypogonadism
Male
hypogonadotropi
c hypogonadism
Male infertility
Ovulation
induction

Korea,

Etanerce
pt

Russia

Rituxima
b

Rheumatoid
arthritis
Ulcerative colitis
Ankylosing
spondylitis
Juvenile
idiopathic
arthritis
Psoriatic arthritis
Rheumatoid
arthritis
Chronic lymphoid
leukemia
Microscopic
polyarteritis
nodosa
Non-Hodgkin's
lymphoma
Rheumatoid
arthritis
Wegener's
granulomatosis

Sinusitis, Upper
respiratory
infection
Injection site
reaction, Rhinitis,
Upper respiratory
infection

Hypotension, Nigh
sweats, Pruritus,
Rash, Abdominal
pain, Diarrhea,
Anemia, Arthralgia
Increasing
frequency of
cough, Rhinitis