GREATER COMPETITION AMONG GENERIC AND BIOSIMILAR MANUFACTURERS

To advocate for legislation and regulations that promote greater competition among generic and biosimilar pharmaceutical manufacturers.

This policy supersedes ASHP policy 0222.

Rationale

A healthy market for generic drug products and biosimilars increases patient access to drugs and lowers drug costs. ASHP recognizes several threats to the health of that market and advocates legislative and regulatory solutions: speeding FDA approval of generic drug applications, especially for lifesaving drugs; reducing drug monopolies by incentivizing competition for additional market entrants; targeting exclusivity protections to truly innovative products; and curbing abuse of risk evaluation and mitigation strategies (REMS) and misuse of FDA’s citizen petition process. In 2015, the FDA faced a backlog of nearly 4,000 generic drug applications, with the approval process taking three years or more. ASHP advocates that the FDA be provided the resources needed to evaluate and approve generic drug applications in a safe and timely manner. ASHP also advocates government and market incentives to increase competition for expensive drugs where no competitors exist and encourage additional market entrants. ASHP has long recognized that agreements between generic and brand-name manufacturers when a product’s market exclusivity is about to expire have the effect of delaying the marketing of competitor products and limiting patient access to affordable generic drugs. ASHP advocates for legislative and regulatory solutions to limit such agreements, as well as solutions to prevent brand-name manufacturers from extending market exclusivity and preventing market entry by generics by slightly altering the formulation of a product. ASHP further advocates legislation that would prevent frivolous patent infringement litigation by brand-name manufacturers, which is reported to have been initiated with the sole intent to extend market exclusivity. Another solution advocated by ASHP is curbing misuse of REMS, which are reported to have been used to prevent generic manufacturers from accessing drug products. In addition, ASHP advocates for more consumer-accessible information on drug prices and rebates, including an annual report on increases in drug prices, which would provide patients and their healthcare providers with the information they need to make drug purchasing choices. Finally, ASHP encourages appropriate federal review of anticompetitive practices by pharmaceutical manufacturers.