A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products.

摘要

The WHO guidelines on evaluating biosimilar products represent an important step forward in the global harmonization of biosimilar(1) products regulation, and provide clear guidance for regulatory bodies and industry. They confirm the key principles of biosimilarity, namely stand alone manufacturing process development and demonstrated comparability, which are described in many existing regional guidelines for biosimilars. Based on the premise that companies which have developed capabilities for the production of safe and efficacious recombinant biopharmaceuticals also have the foundation and tools available to make safe and efficacious biosimilars, the guidelines provide industry with clear direction on how to actually do so. Finally, when applying the WHO guidelines, it should be considered that the experience gained by industry and regulators when evaluating manufacturing process changes of originator products can be leveraged and directly applied to the development and approval of biosimilar products.