Which statement about biosimilars is NOT correct?

Biosimilars are not considered generic pharmaceuticals because they are not identical copies of the original biologic products. Instead, they are highly similar to an already FDA-approved biologic drug, known as the reference product. This distinction is crucial since biologics are complex molecules derived from living organisms, and their manufacturing processes can introduce variability. Unlike traditional generic drugs, which are chemically identical to their branded counterparts, biosimilars require a unique regulatory pathway to ensure they have no clinically meaningful differences in terms of safety and efficacy compared to the original product.

The other statements are accurate reflections of the biosimilars regulatory framework. Biosimilars undergo marketing review procedures similar to those for biologics, but with considerations for their unique characteristics. These products must also demonstrate similarity through clinical studies, focusing on attributes such as safety, potency, and efficacy. Moreover, even though biosimilars are tailored to match their reference products, they may utilize different production processes and raw materials, reflecting the complexities inherent in biologic manufacturing. Understanding these nuances is essential for recognizing the regulatory landscape surrounding biosimilars.