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Driving Access to Affordable Drugs

Why Employers Care

Employers have a direct and growing interest in patent reform policies and other measures that expand access to lower-cost generics and biosimilars. When patents on brand-name drugs expire, the timely introduction of biosimilars and generics leads to greater market competition and lower prescription drug prices, helping reduce overall health care costs for both employers and their employees. However, current regulatory and patent system inefficiencies often delay this access. That’s why employers support the following reforms to create a more transparent, competitive pharmaceutical marketplace, including:

  • Streamlining biosimilar interchangeability requirements;
  • Improving coordination between the Food and Drug Administration (FDA) and U.S. Patent and Trademark Office (PTO) to prevent the misuse of patent filings that block competition; and
  • Thoughtfully considering international pricing provisions that can impact domestic pricing strategies.

Ultimately, advancing these reforms helps employers manage rising health care costs, ensure access to affordable, high-quality medications, and maintain sustainable, competitive health benefits programs that support the health and financial security of their workforce.

Streamlining Biosimilar Interchangeability Requirements

Biosimilars offer safe, effective, and lower-cost alternatives to brand-name biologic medications, yet overly complex interchangeability requirements have slowed their widespread adoption.

Simplifying these regulatory hurdles will empower pharmacists and providers to more readily substitute biosimilars, increasing competition and delivering savings to patients, employers, and health plans alike.

Advancing Patent Policies

Practices like “patent thickets”, “evergreening”, and others extend monopolies on brand-name drugs well beyond intended patent lifespans. Employers support tackling these practices and enhanced coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO) to prevent the misuse of patent filings that delay the entry of affordable generics and biosimilars.

Better collaboration between these agencies can help identify and address abusive practices early, protecting market competition and improving access to cost-effective medications.

Medication Affordability and Patent Integrity Act (S. 2780 and H.R. H.R. 5429 – 118th Congress)

Interagency Patent Coordination and Improvement Act of 2023 (S. 79 and H.R. 1717 – 118th Congress)

Preserve Access to Affordable Generics and Biosimilars Act (S. 142 – 118th Congress)

Stop STALLING Act (S. 148 – 118th Congress)

Affordable Prescriptions for Patients Act of 2023 (S. 150 and H.R. 9070 – 118th Congress)

A Bill to Address Patent Thickets (S. 3583 and H.R. 6986 – 118th Congress)

Prescription Pricing for the People Act of 2023 (S. 113 – 118th Congress)

Other Resources

Thoughtfully Considering International Pricing Provisions

Proposals that link U.S. drug prices to international pricing benchmarks must be carefully evaluated for their potential to affect domestic markets. Employers believe pricing strategies should prioritize sustainable access and affordability for American patients and plan sponsors while encouraging pharmaceutical innovation. Thoughtful, evidence-based approaches to international pricing provisions can help balance these goals without creating unintended cost pressures at home.