Abstract
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.
Highlights
Biopharmaceuticals are a cornerstone of therapy for a wide spectrum of disorders, from cancer to autoimmune or autoinflammatory diseases
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
This review summarises the opinion of a Swiss expert panel on the various aspects of biosimilar development, and highlights the key points that should be taken into account when facing the choice between biosimilar and original
Summary
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). 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.
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