Welcome to the fourth edition of Biosimilars Newsletter, a quarterly publication dedicated to keeping you updated on current biosimilars news, including the global regulatory landscape, biosimilars articles and reports, and company news as reported via company press releases. The “hot topic” for this edition discusses the crucial, but often overlooked, part played of bioanalytical method development and validation in the marketing authorization of a Biosimilar and safety of patients. The article discusses several of the practical steps which should be taken into account during validation and bioanalysis required to determine pharmacokinetics (PK), to monitor immunogenicity (anti-drug antibody, ADA, assays), and to assess key pharmacodynamic parameters (PD).
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