351(k) Application

A 351(k) application is a regulatory process used by pharmaceutical companies to get approval for a new generic or biosimilar drug. It allows them to demonstrate that their product is highly similar to an already approved "reference" drug and that there are no significant differences in safety or effectiveness. This streamlined process helps bring affordable alternatives to market more quickly, provided the company can show they meet specific standards for similarity and quality, reducing the need for extensive new clinical testing.