Jonathan St-Germain: “In order to reach a consensus on clear regulatory criteria and optimal practices, it is critical to involve participants from various areas in the discussion on biosimilars. Because of the relatively new arrival of protein therapeutics in the bioanalytical industry, the field would greatly benefit from the input of protein experts from both industry and academia in the fields of proteomics, biochemistry, protein chemistry and even biology. Their input, experience and knowledge, combined with the expertise of bioanalytical scientists and regulatory specialists, would greatly speed up the process of generating relevant regulatory guidelines.”
Arno Kromminga: “Excellent regulatory guidelines exist. With the increasing number of biosimilars more monographs will be published. Standardized positive controls for the immunogenicity assays are under development and some are already available (e.g. antibodies against erythropoietin).”
Paul Declerck: “In the ‘developed’ world, the approval process is quite well regulated.”
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