A new WHO Q&A supplements existing guidelines for the regulatory evaluation of biosimilar products. The document has been adopted by the WHO Expert Committee on Biological Standardization. The Q&A serves to clarify guiding principles included in the Guidelines on similar biotherapeutic products and on similar monoclonal antibodies.
Taken together, these three documents provide up-to-date guidance on evaluation of biosimilar products. Biosimilars provide additional and more affordable treatment options to patients. WHO’s role is to support countries in efforts to provide affordable quality-assured treatments to their populations.
Taken together, these three documents provide up-to-date guidance on evaluation of biosimilar products. Biosimilars provide additional and more affordable treatment options to patients. WHO’s role is to support countries in efforts to provide affordable quality-assured treatments to their populations.