Biosimilar Products Scientific Principles , Challenges , and Opportunities

T he Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and regulatory aspects in the development of biosimilar products. Such products are becoming an increasingly important area of interest for both the biopharmaceutical industry and regulatory agencies. Biosimilars are highly complex, and scientists have been unable to demonstrate identity to a level typically possible for small molecules. Consequently, specific scientific and regulatory approaches are required to ensure a high degree of similarity that is sufficient to ref lect the safety and efficacy of reference products. The purposes of this forum were to highlight scientific and regulatory challenges for developing and assessing biosimilar products and to discuss industry opportunities. Presentations included case studies of experiences gained with the first biosimilar products (e.g., in Europe and Canada), examples addressing recent efforts in developing biosimilar monoclonal antibody (MAb) products, and specific regulatory guidance. Participants discussed development and regulatory expectations associated with the biosimilar approaches for those cases. Discussions focused on analytical characterization of biosimilars and reference products, preclinical and clinical aspects around biosimilarity evaluation, development of biosimilar MAbs, naming, goalposts for similarity at the quality level, and global development as applicable to biosimilars.