Publication

The advent of biosimilars: challenges and risks

Journal Paper/Review - Jul 1, 2014

Units
PubMed
Doi

Citation
Müller R, Renner C, Gabay C, Cassata G, Lohri A, Hasler P. The advent of biosimilars: challenges and risks. Swiss Med Wkly 2014; 144:w13980.
Type
Journal Paper/Review (English)
Journal
Swiss Med Wkly 2014; 144
Publication Date
Jul 1, 2014
Issn Electronic
1424-3997
Pages
w13980
Brief description/objective

Biosimilars represent a new class of medicinal products that will have significant impact on clinical use. They are identical on an amino acid sequence level to existing reference biopharmaceutical products (originals). However, they may exhibit differences on a protein level. This paper provides a brief overview of biosimilar development and describes the risk and challenges that should be considered during the admission of biosimilars into the clinic.