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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.

  • Biosimilar Red Tape Elimination Act (S. 1954 and H.R. 5526)
    • This bill removes certain requirements for biosimilars to be designated as interchangeable. Specifically, it establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar. The FDA may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.
  • Lee Bill Cuts Drug Prices and Red Tape (06.04.2025)
    • Senators introduced the legislation  which would immediately deem FDA-approved biosimilars as interchangeable with their brand-name counterparts—eliminating redundant “switching study” requirements—to streamline approval, boost competition, and reduce drug prices. Supporters emphasize that this will empower pharmacists to substitute lower-cost biosimilars, potentially saving consumers billions while upholding safety standards.
  • Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans (09.10.2025)
    • This press release explains that would improve patient access to lower-cost prescription medications and increase competition in the biological drug market by automatically deeming “biosimilar” drugs as interchangeable with their name-brand counterparts upon FDA approval.
  • One-Pager on S. 1954
    • The bill aims to lower drug costs by eliminating the FDA’s burdensome “interchangeability” designation for biosimilars, which has created confusion and restricted pharmacist substitution. The bill would automatically deem all FDA-approved biosimilars as interchangeable, eliminate costly switching study requirements, and align U.S. policy with international scientific consensus showing no added risk from switching—ultimately streamlining access, promoting competition, and generating billions in potential savings.
  • FTC/DOJ Listening Session on Lowering Drug Prices
    • The first listening session, “Lowering Americans’ Drug Prices Through Competition”, focused on anticompetitive conduct related to patent abuses (e.g. patent thickets), regulatory approval obstacles (e.g., interchangeability standards), and PBM practices. ERIC’s President and CEO, James Gelfand, participated in the listening session and presented information on the importance of generics and biosimilars to help lower overall drug spending by employer plans and employees. In his remarks, he discussed PBM rebating practice, the need to get rid of interchangeability standards, and patent trolling. He pointed out several bills that ERIC supports in Congress to improve the market and how best to work with the agencies.
  • Labeling for Biosimilar and Interchangeable Biosimilar Products; Guidance for Industry DRAFT GUIDANCE (FDA-2016-D-0643)
    • ERIC comments to FDA appreciating the withdrawal of guidance specifying that an interchangeability statement be included in the labeling of products licensed as interchangeable. This signals a positive step towards ensuring competition and access to biosimilars.
  • Considerations in Demonstrating Interchangeability with a Reference Product: Update; Draft Guidance for Industry [Docket No. FDA-2017-D-0154]
    • ERIC applauds the FDA for recognizing the switching study requirement as a hurdle which delays and prevents competition. Removal of the switching study requirement does not compromise safety, efficacy, or quality.
  • More information on biosimilars cost savings and competition
    • ERIC’s research on expanding access to biosimilars has been shown to significantly lower drug spending and increase market competition, reinforcing the need for streamlined policies that facilitate their use.

Advancing Patent Policies

Practices like “patent thickets,” “evergreening,” and others extend monopolies on brand-name drugs well beyond intended patent lifespans. ERIC supports commonsense solutions to address such anticompetitive practices. Furthermore, ERIC supports effort to streamline 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.

  • Comments on the Revision to Rules of Practice Before the Patent Trial and Appeal Board
    • ERIC called for the U.S. Patent and Trademark Office (USPTO) to withdraw its proposed rule revising PTAB procedures as it would limit access to the inter partes review (IPR) process which is an essential mechanism for challenging low-quality patents that keep drug prices artificially high by delaying competition from lower cost generic and biosimilar medications. Limiting access to the IPR process will not only undermine efforts to lower health care costs, but this action will directly contradict President Trump’s stated priority to make prescription drugs more affordable for Americans.

Prescription Pricing for the People Act of 2025 (S. 527)

Affordable Prescriptions for Patients Act (S. 1041)

Stop STALLING Act (S. 1095)

Preserve Access to Affordable Generics and Biosimilars Act (S. 1096)

Interagency Patent Coordination and Improvement Act of 2025 (S. 1097)

Eliminating Thickets to Increase Competition Act (ETHIC) Act (S. 2276 and H.R. 3269).

  • Eliminating Thickets to Increase Competition Act (ETHIC) Act
    • This legislation targets the practice of creating patent thickets that delay generic drug competition.
    • Senate Press Release This press releases announces the introduction of the legislation naimed at streamlining patent litigation for brand-name drugs by limiting companies to asserting one patent per “thicket,” preventing multiple lawsuits against the same generic or biosimilar competitor, and safeguarding genuine innovation—all to accelerate market entry of lower-cost alternatives and reduce prescription drug costs for patients
  • House Press Release
    • Rep. Jodey Arrington introduced the bipartisan ETHIC Act to lower prescription drug costs by limiting abusive patent practices that block generic and biosimilar competition.
  • House Judiciary Group Letter
    • The letter supports curbing excessive and duplicative patents used to prolong exclusivity.
  • Welch, Braun, Klobuchar USPTO Rule Letter (9.19.2024)
    • Lawmakers applauded USPTO’s rulemaking to rein in patent abuse and lower drug prices.

Medication Affordability and Patent Integrity Act (S. 2658)

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.

  • ERIC Statement – House E&C Affordability Hearing (1.31.24)
    • ERIC emphasized that there has been various strategies, such as “international free-riding” that escape competition and result in n unconscionable prices and costs to plan
    • sponsors and patients.
  • House Budget Health Task Force RFI (10.13.23)
    • The response to this RFI underscored the need to address market failures including “international free-riding” where Americans pay higher drug costs than other industrialized nations.
  • 2022 Affordability RFI (2.4.22)
    • ERIC supports addressing issues related to so-called “international free-riding” wherein Americans pay vastly higher drug costs than other wealthy, industrialized nations.
  • E&C Prescription Drug Statement (5.4.21)
    • The statement called for a balanced approach that evaluates international pricing models while preserving incentives for biopharmaceutical innovation in the U.S.

Media

  • Congress Can Save the Biosimilar Market and Patients’ Wallets, DC Journal (8.1.2025)  
    • DC Journal ran an op-ed penned by ERIC President and CEO James Gelfand where he sets forth the need for Congress to eliminate switching studies that delay interchangeability with regards to biosimilar approvals. In his op-ed, he endorsed S.1954, the “Biosimilar Red Tape Elimination Act,” introduced by Sens. Mike Lee (R-UT) and Ben Ray Luján (D-NM), which eliminates those studies, which he argues “serve no purpose other than delaying Americans’ access to lower-cost biosimilar alternatives.
  • Drug Price Gouging Debated at FTC/DOJ Hearing, Plan Sponsor Council of America (7.2.2025)
    • The FTC and DOJ held a public “listening session” on June 30, 2025, to gather expert testimony on anticompetitive pharmaceutical practices, with ERIC’s CEO James Gelfand highlighting how employer-sponsored plans are burdened by inflated drug prices and opaque PBM tactics — such as hiding pricing data and steering patients toward more expensive brand-name medications — while experts also shed light on patent abuses and “pay-for-delay” schemes that suppress generic and biosimilar competition
  • Finish the Job – Enact PBM Reform Blog Post
    • This blog calls for pharmacy benefit manager (PBM) reforms and comprehensive policy solutions to reduce drug costs and increase competition to allow for more generics and biosimilars to come to market.