What are biosimilars?

Biosimilars are defined as biologic medical products that are highly similar to an already approved reference product, known as a reference biologic. These products are developed to meet stringent regulatory standards that ensure their similarities to the original biologic in terms of safety, efficacy, and quality. This means that while biosimilars may not be identical to the reference product due to the inherent variability of biologics, they demonstrate no clinically meaningful differences in terms of their therapeutic effects.

This is particularly important in biotechnology because biologics are typically large, complex molecules made from living organisms, which cannot be exactly replicated. As a result, biosimilars provide an essential opportunity to expand patient access to biologic therapies, often at a reduced cost compared to the reference product, thereby playing a significant role in healthcare affordability and accessibility.

The other choices do not accurately describe biosimilars. Products made from synthetic chemicals do not qualify as biologics; vaccines are a specific type of biologic but do not encompass the full definition of biosimilars, and generic versions apply to small molecule medications, not biologics, which are classified separately due to their complexity and production methods.