Loading...
Biosimilars: what clinicians should know.
Weise, Martina Bielsky, Marie-Christine De Smet, Karen Ehmann, Falk Ekman, Niklas Giezen, Thijs J Gravanis, Iordanis Heim, Hans-Karl Heinonen, Esa Ho, Kowid
Weise, Martina
Bielsky, Marie-Christine
De Smet, Karen
Ehmann, Falk
Ekman, Niklas
Giezen, Thijs J
Gravanis, Iordanis
Heim, Hans-Karl
Heinonen, Esa
Ho, Kowid
Citations
Altmetric:
Advisors
Editors
Other Contributors
Issue Date
2012-12-20
Submitted date
Files
Loading...
original manuscript
Adobe PDF, 274.8 KB
Other Titles
Abstract
Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators.
Citation
Biosimilars: what clinicians should know. 2012, 120 (26):5111-7 Blood
Publisher
Journal
PubMed ID
PubMed Central ID
Additional Links
Embedded video
Type
Article
Language
en
Description
Series/Report no.
ISSN
1528-0020
EISSN
ISBN
ISMN
Gov't Doc #
Sponsors
License
Archived with thanks to Blood