These guidelines are intended to guide applicants on the Chemistry, Manufacturing and Control
(CMC) section of a listing application for proposed similar biotherapeutic products. The
application must include information demonstrating biosimilarity, based on data derived from,
among other things, analytical studies that demonstrate that the biotherapeutic product is highly
similar to the Reference Biotherapeutic Product notwithstanding minor differences in clinically
inactive components.
Although the regulatory framework applies generally to biotherapeutic products, this guidance
document focuses on similar biotherapeutic products and provides an overview of the quality,
non-clinical and clinical factors to consider in demonstrating biosimilarity between a proposed
biotherapeutic product and the reference product.
Similar Biotherapeutic Products (SBPs) can be approved based, in part, on an exercise to
demonstrate similarity to an already approved Reference Biotherapeutic Product (RBP) by
Stringent Regulatory Authorities (SRAs). The same RBP should be used throughout the
comparability program in order to generate coherent data and conclusions. Comparative quality,
non-clinical and clinical studies are needed to substantiate the similarity of structure/composition,
quality, safety and efficacy between the biosimilar and the reference biotherapeutic product. The
pharmaceutical form, strength/concentration and route of administration should be the same as
that of the reference product. Any differences between the similar biotherapeutic product and the
reference biotherapeutic product should be justified by appropriate studies.
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