What Regulators Want
By Bruno Speder, Head Clinical Regulatory Affairs & Consultancy at SGS
Bruno Speder |
Head to head
The Chemistry, Manufacturing and Control (CMC) dossier is an essential part of the submission package for any pharmaceutical product to enter a clinical trial and, in a later stage, for an application for market authorization. For a biosimilar, the CMC part is even more important and the core of a biosimilar’s dossier is a comprehensive head-to-head comparison of the biosimilar and the originator product, including points of difference between the two products, and how these will affect the product. The dossier must also include all details of the analytical (and other) methods that have been used to identify these differences (allowing the assessor at the regulatory agency to decide just how similar the two products actually are), as well as manufacturing details (including cell lines and sources of material), a description of the process control methods used, and information about how analytical data have been validated.
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