Enabling Biogenerics: Exploiting Comparability to Limit Clinical Trial Needs

This Health Industry Insights Perspective describes analyst perspectives in response to recently proposed legislation to enable the approval of generic biological drugs (biogenerics) by the U.S. Food and Drug Administration (FDA). The proposed legislation aspires to provide competitive pressure to develop generic alternatives to FDA-approved biological drugs that have exhausted patent protections with the overall goal of decreasing drug costs for consumers.