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ASHO position paper on Biosimilars

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This position paper on the clinical use of biosimilars presents the consensus of an expert group who met on June 19, 2009 in Vienna at the initiative of the Austrian Society of Hematology and Oncology (ASHO).

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References

  1. Arzneimittelkommission der deutschen Ärzteschaft: Stellungnahme der Arzneimittelkommission der deutschen Ärzteschaft zur Biosimilars. www.akdae.de (12/2008).

  2. Crommelin D, Bermejo T, Bissig M, Damiaans J, Krämer I, Rambourg P, Scroccaro G, Strukeij B, Tredree R. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecularweight pharmaceuticals. Eur J Hosp Pharm Sci, 2005.

  3. Declerck PJ. Biotherapeutics in the era of biosimilars. Drug Safety, 2007.

  4. Krämer I, Jelkmann W. Rekombinante Arzneimittel – medizinischer Fortschritt durch Biotechnologie. Springer Verlag, 2008.

  5. Krämer, Tredree, Vulto EJHPP. 14: 73–76, 2008.

  6. Longstaff C, Whitton CM, Stebbings R, Gray E. How do we assure the quality of biological medicine. Drug Discovery Today, 2009.

  7. Mellstedt H, Nieserwieser D, Ludwig H. Review: the challenge of biosimilars. Ann Oncol, 2007.

  8. EMEA, Committee for Medicinal Products for Human Use (CHMP): guidelines and guidance on similar medicinal products containing biotechnology-derived proteins as active substance

  9. http://www.emea.europa.eu/pfds/human/biosimilar/4283205en.pdf

  10. http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf

  11. http://www.emea.europa.eu/pdfs/human/biosimilar/143706en.pdf

  12. http://www.emea.europa.eu/pfds/human/biosimilar/10169506enfin.pdf

  13. http://www.emea.europa.eu/pfds/human/biosimilar/9452605en.pdf

  14. http://www.emea.europa.eu/pfds/human/biosimilar/3132905en.pdf

  15. http://www.emea.europa.eu/pfds/human/biosimilar/3277505en.pdf

  16. http://www.emea.europa.eu/htms/human/epar/eparintro.htm

  17. http://www.emea.europa.eu/humandocs/PDFs/EPAR/nutripinaq/437400en6.pdf

  18. http://tga.gov.au/DOCS/pdf/euguide/bmwp/9452805en.pdf

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Authors and Affiliations

  1. Department Internal Medicine, University Hospital of Internal Medicine V, Hematology and Oncology, Anichstrasse 35, A-6020, Innsbruck, Austria

    Günther Gastl MD (Clinical Director)

  2. Department Internal Medicine, LKH Klagenfurt, Klagenfurt, Austria

    D. Geissler

  3. Department Internal Medicine, KH Hietzing, Hietzing, Austria

    K. Geissler

  4. Department Internal Medicine, LKH Feldkirch, Feldkirch, Austria

    A. Lang

  5. Internal Department, Wilhelminenspital, Vienna, Austria

    H. Ludwig

  6. University Hospital of Clinical Pharmacology, AKH Vienna, Vienna, Austria

    M. Müller

  7. Institute of Pharmacology, Medical University Vienna, Vienna, Austria

    H. Sitte

Authors
  1. Günther Gastl MD
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  2. D. Geissler
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  3. K. Geissler
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  4. A. Lang
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  5. H. Ludwig
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  6. M. Müller
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  7. H. Sitte
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Corresponding author

Correspondence to Günther Gastl MD.

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Gastl, G., Geissler, D., Geissler, K. et al. ASHO position paper on Biosimilars. memo 2, 232–233 (2009). https://doi.org/10.1007/s12254-009-0162-2

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  • DOI: https://doi.org/10.1007/s12254-009-0162-2

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