Biosimilars access toolkit

Biologicals are a diverse group of medicines which include vaccines, growth factors, immune modulators, and monoclonal antibodies, as well as products derived from human blood and plasma. They are used in the treatment of many life-threatening chronic conditions such as diabetes, cancers, heart disease, multiple sclerosis, anemia, and rheumatoid arthritis.

A biosimilar is a biological product has highly similar quality, safety, and efficacy to an already licensed biological product. Biosimilars provide more therapeutic options and offer improved access to biotherapeutic products due to the promise of better affordability as compared to innovator products; however, their availability is still low in many low- and middle-income countries.

Since the World Health Assembly resolution WHA67.21 on access to biotherapeutics in 2014, WHO has created a number of tools in support of access to biosimilar products for use by manufacturers, regulators and policy makers. The following tools provide guidance to address specific areas of the value chain from initial identification of active substances to regulatory and policy tools to facilitate access.