Publikation
The advent of biosimilars: challenges and risks
Wissenschaftlicher Artikel/Review - 01.07.2014
Müller Rüdiger, Renner Christoph, Gabay Cem, Cassata Giuseppe, Lohri Andreas, Hasler Paul
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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.