Biosimilar Therapeutic Monoclonal Antibodies:Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 2

摘要

Last month, Part 1 of this discussion briefly described the regulatory landscape for developing biosimilar therapeutic monoclonal antibodies (TMAbs). We identified certain specific structural components of TMAb drug substances that warrant particularattention because alterations to them are likely to affect therapeutic safety and effectiveness. Now we conclude by considering whether studies of reference materials can further the development of analytical industry standards to ensure comparability ofputative biosimilar TMAbs with innovator TMAbs. We suggest that the time is right to tie analytical industry standards and manufacturing controls with specific reductions in preclinical and clinical studies for regulatory approval of certain biosimilarTMAbs.