Biomanufacturing Changes: Trenches Littered With Lessons Learned

A comparability template for biomanufacturing changes could serve as a model for biosimilars - but only if one can be established. As the dream of well-characterized biologics falters despite growing analytical prowess, industry and FDA are resigned to a case-by-case approach to comparability. Discussions at a recent DIA meeting focus on how to converge toward a common set of best practices, starting with a decision tree and testing hierarchy. The dominant role of bioequivalence PK studies in demonstrating biosimilarity is questioned. The difficulty of powering up animal studies sufficiently to detect subtle differences is discussed. Lessons learned are shared. Early and frequent discussion with FDA is encouraged to cut down on 'just in case' studies. Pending biosimilars legislation would set comparable 'highly similar' standards.