Changes made to biotherapeutic products and biosimilars should be similarly monitored worldwide, and industry should provide information uniformly and timely.
To achieve such uniformity, World Health Organization released draft guidelines on procedures and data requirements for changes to approved biotherapeutic products and biosimilars or to the information associated with the product. Any change to a biotherapeutic product or biosimilar may impact quality, safety and/or efficacy of that product, any change to the information associated with the product (i.e. product labeling information) may impact its safe and effective use. These statements seem quite obvious, but uniformity in reporting changes regarding biologics had not been achieved yet.
According to the guidance, industry should classify proposed change into one of the following groups: safety and efficacy change, product labeling information change, urgent product labeling information change or administrative product labeling information change.
Furthermore, WHO categorized changes in quality characteristics as major, moderate, minor or changes with no impact. In some cases, additional clinical or preclinical studies may be required to support the change.
Organization also proposes a list of documents that should be requested by a local regulator and submitted by industry to support the change. This includes GMP compliance data, pharmacovigilance data, clinical and preclinical study results (full list of proposed documents is available through the link below).
Organization will accept proposed changes to the guidance until December 16th.