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  • Side Effect & Indication Biosimilar

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    This document provides information on 16 biosimilar drugs approved in various markets and their indications, side effects, and approved regions. The biosimilars treat conditions such as neutropenia, anemia, growth hormone deficiency, diabetes, cancers, and autoimmune diseases. Common side effects across biosimilars include rash, diarrhea, headaches, and injection site reactions. The biosimilars have been approved in major markets like the EU, US, Japan, Australia and others.

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    This document provides information on 16 biosimilar drugs approved in various markets and their indications, side effects, and approved regions. The biosimilars treat conditions such as neutropenia, anemia, growth hormone deficiency, diabetes, cancers, and autoimmune diseases. Common side effects across biosimilars include rash, diarrhea, headaches, and injection site reactions. The biosimilars have been approved in major markets like the EU, US, Japan, Australia and others.

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    23 views3 pages

    Side Effect & Indication Biosimilar

    Uploaded by

    supanee kittitanyapon
    This document provides information on 16 biosimilar drugs approved in various markets and their indications, side effects, and approved regions. The biosimilars treat conditions such as neutropenia, anemia, growth hormone deficiency, diabetes, cancers, and autoimmune diseases. Common side effects across biosimilars include rash, diarrhea, headaches, and injection site reactions. The biosimilars have been approved in major markets like the EU, US, Japan, Australia and others.

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    © All Rights Reserved
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    of 3

    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

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