Although biologic drugs make up only 5% of US prescriptions, they account for more than half of all drug spending—a gap the FDA seeks to narrow through new guidance to accelerate biosimilar development.

The US Food and Drug Administration issued a draft guidance aimed at streamlining biosimilar drug development to reduce costs and accelerate patient access to lower-priced biologic therapies. The proposal outlines significant changes to simplify biosimilarity assessments and minimize unnecessary clinical trials, with the goal of improving efficiency without compromising safety or efficacy.

Despite their therapeutic equivalence to branded biologics, biosimilars currently hold less than 20% of the market. Since the first biosimilar approval in 2015, the US Food and Drug Administration (FDA) has authorized 76 products, a small proportion compared with the more than 30,000 approved generic drugs. Fewer than one in ten biologic drugs anticipated to lose patent protection in the next decade currently have a biosimilar in development, according to the FDA.

The new guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, reflects the agency’s accumulated experience since 2015. Comparative efficacy studies—often taking 1 to 3 years and costing roughly $24 million—have demonstrated limited sensitivity relative to analytical testing. In certain cases, developers have conducted switching studies to support the licensure of biosimilars as interchangeable, a requirement not applied to generic drugs. The FDA’s new guidance indicates that such studies are typically unnecessary and are no longer generally recommended.

The FDA’s initiative aligns with the Biologics Price Competition and Innovation Act of 2010, which established a pathway for biosimilars to promote market competition. The agency expects the new guidance to facilitate faster entry of high-quality biosimilars into the US market.

Source: FDA