Scribd Logo
Upload

Welcome to Scribd!

  • BIOSIMILARS

    Uploaded by

    nosfar
    29 views3 pages
    This document provides information on various biosimilar products that have been approved in Europe including the active substance, therapeutic area, reference product they are similar to, marketing authorization holder and date of approval. It includes biosimilars to epoetin alfa, filgrastim, somatropin and insulin as well as some products that were refused or withdrawn. The table lists 21 biosimilar products across several different drug classes.

    Original Description:

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document provides information on various biosimilar products that have been approved in Europe including the active substance, therapeutic area, reference product they are similar to, marketing authorization holder and date of approval. It includes biosimilars to epoetin alfa, filgrastim, somatropin and insulin as well as some products that were refused or withdrawn. The table lists 21 biosimilar products across several different drug classes.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    29 views3 pages

    BIOSIMILARS

    Uploaded by

    nosfar
    This document provides information on various biosimilar products that have been approved in Europe including the active substance, therapeutic area, reference product they are similar to, marketing authorization holder and date of approval. It includes biosimilars to epoetin alfa, filgrastim, somatropin and insulin as well as some products that were refused or withdrawn. The table lists 21 biosimilar products across several different drug classes.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 3

    Name of biosimilar Active Therapeutic Reference Date of

    product substance EMEA Number Area MAH product approval


    Medice
    Anemia Kidney Arzneimittel
    EMEA/H/C/00072 Failure, Chronic Pütter GmbH &
    Abseamed epoetin alfa 7 Cancer Co. KG Eprex/Erypo 28/8/2007
    EMEA/H/C/00072 Anemia Kidney
    Binocrit epoetin alfa 5 Failure, Chronic Sandoz GmbH Eprex/Erypo 28/8/2007
    Anemia Kidney
    EMEA/H/C/00072 Failure, Chronic
    Epoetin alfa Hexal epoetin alfa 6 Cancer Hexal AG Eprex/Erypo 28/8/2007
    Anemia Kidney
    Failure, Chronic
    Blood
    Transfusion,
    EMEA/H/C/00087 Autologous Hospira UK
    Retacrit epoetin zeta 2 Cancer Limited Eprex/Erypo 18/12/2007
    Anemia Kidney
    Failure, Chronic
    Blood
    Transfusion,
    EMEA/H/C/00076 Autologous STADA
    Silapo epoetin zeta 0 Cancer Arzneimittel AG Eprex/Erypo 18/12/2007
    EMEA/H/C/00082 CT Arzneimittel Neupogen /
    Biograstim filgrastim 6 Neutropenia GmbH Granulokine 15/9/2008
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00091 Transplantation Neupogen/Granulok
    Filgrastim Hexal filgrastim 8 Cancer Hexal AG ine 6/2/2009
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00082 Transplantation Ratiopharm Neupogen/Granulok
    Filgrastim ratiopharm filgrastim 4 Cancer GmbH ine 15/9/2008

    1
    Name of biosimilar Active Therapeutic Reference Date of
    product substance EMEA Number Area MAH product approval
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00114 Transplantation Neupogen/Granulok
    Nivestim filgrastim 2 Cancer Hospira UK Ltd ine 8/6/2010
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00082 Transplantation Ratiopharm Neupogen/Granulok
    Ratiograstim filgrastim 5 Cancer GmbH ine 15/9/2008
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00082 Transplantation Teva Generics Neupogen/Granulok
    Tevagrastim filgrastim 7 Cancer GmbH ine 15/9/2008
    Neutropenia
    Hematopoietic
    Stem Cell
    EMEA/H/C/00091 Transplantation Neupogen/Granulok
    Zarzio filgrastim 7 Cancer Sandoz GmbH ine 6/2/2009
    Insulin Marvel Diabetes Marvel Life
    Intermediate human insulin WITHDRAWN Mellitus Sciences
    Diabetes Marvel Life
    Insulin Marvel Long human insulin WITHDRAWN Mellitus Sciences
    Diabetes Marvel Life
    Insulin Marvel Short human insulin WITHDRAWN Mellitus Sciences
    recombinant
    human
    interferon- Hepatitis C, BioPartners
    Alpheon alfa-2a REFUSED Chronic GmbH Roferon-A REFUSED
    Turner
    Syndrome
    Dwarfism,
    EMEA/H/C/00060 Pituitary Prader-
    Omnitrope somatropin 7 Willi Syndrome Sandoz GmbH Genotropin 12/4/2006

    2
    Name of biosimilar Active Therapeutic Reference Date of
    product substance EMEA Number Area MAH product approval
    Dwarfism,
    Pituitary
    EMEA/H/C/00060 Turner BioPartners
    Valtropin somatropin 2 Syndrome GmbH Humatrope 24/4/2006

    You might also like