Biotherapeutic products (biotherapeutics) have a successful record in
treating many life-threatening and chronic diseases. However, their cost has often been high, thereby limiting
their access to patients, particularly in developing countries. Recently, the
expiration of patents and/or data protection for the first major group of originator's biotherapeutics has
ushered in an era of products that are designed to be "similar" to a licensed originator product.
These products rely, in part, for their licensing on prior information regarding safety and efficacy
obtained with the originator products. The clinical experience and established safety profile of
the originator products should contribute to the development of similar biotherapeutic products
(SBPs). A variety of terms, such as "biosimilar products", "follow-on protein products"
and "subsequent-entry biologics" have been coined by different jurisdictions to describe these
The term "generic" medicine is used to describe chemical, small molecule
medicinal products that are structurally and therapeutically equivalent to an originator product whose
patent and/or data protection period has expired. The demonstration of bioequivalence of the
generic medicine with a reference product is usually appropriate and sufficient to infer therapeutic
equivalence between the generic medicine and the reference product. However, the approach
established for generic medicines is not suitable for development, evaluation and licensing of SBPs
since biotherapeutics consist of relatively large, and complex proteins that are
difficult to characterize. The clinical performance of biotherapeutics can also be much influenced by the
manufacturing process and some clinical studies will also be required to support the safety
and efficacy of a SBP...
The intention of this document is to provide globally acceptable principles
for licensing biotherapeutic products that are claimed to be similar to biotherapeutic
products of assured quality, safety, and efficacy that have been licensed based on a full licensing
dossier. On the basis of proven similarity, the licensing of a SBP will rely, in part, on
non-clinical and clinical data generated with an already licensed reference biotherapeutic product (RBP).
This guideline can be adopted as a whole, or partially, by NRAs worldwide or used as a basis
for establishing national regulatory frameworks for licensure of these products.