On Monday, June 30, 2025, the Department of Justice (DOJ) and the Federal Trade Commission (FTC), in coordination with the Department of Health and Human Services (HHS) and the Department of Commerce (DOC), hosted a listening session titled Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition. The session gathered input from patient advocates, industry leaders, and academics in two panel discussions. As part of implementing President Donald Trump’s Executive Order No. 14273, Lowering Drug Prices by Once Again Putting Americans First, this was the first of three joint agency-led listening sessions focused on improving the affordability of prescription drugs by increasing market access to generics and biosimilars through promoting competition. Per the Executive Order, listening sessions will inform the joint report to be issued by October 12, 2025, on recommendations to address anticompetitive practices in pharmaceutical markets.

The second listening session will take place on Thursday, July 24, 2025, and will focus on Formulary and Benefit Practices and Regulatory Abuse Impacting Drug Competition. The final session will be held on Monday, August 4, 2025, and will focus on Turning Insights into Action to Reduce Drug Prices. A summary of key takeaways from the first listening session is provided below.

PANEL 1: ANTICOMPETITIVE CONDUCT TO DELAY AND FORESTALL COMPETITION FROM LOWER-PRICED ALTERNATIVES

Panelists:

• Sneha Dave, Founder & Executive Director, Generation Patient
• Marcus H. Meier, Former Assistant Director, Health Care Division, Federal Trade Commission
• Hans Sauer, Deputy General Counsel, Vice President for Intellectual Property, Biotechnology Innovation Organization
• Stephen W. Schondelmeyer, PharmD, PhD, Professor at the University of Minnesota College of Pharmacy
• Shashank Upadhye, Partner, Upadhye Tang LLP

The panel highlighted anticompetitive strategies used by brand-name manufacturers and the regulatory barriers that undermine biosimilar or generic competition, ultimately contributing to high drug prices and restricted choices for patients, employers, and health plans. Panelists emphasized the importance of improving patient access to affordable drugs and the division between brand-name manufacturers and generic companies. Panelists agreed that generics and biosimilars are essential for ensuring access to affordable prescription drugs for patients in the US, and that reforms should come from both the industry and federal agencies. Some of the key challenges highlighted include:

• Exclusive supply agreements for key intermediates that are used to produce Active Pharmaceutical Ingredients (APIs). This practice restricts access to a few companies and prevents bulk suppliers from producing the API.
• Patent thickets and low-quality patents: Panelists raised concerns about brand-name companies filing multiple, incremental-change patents for a single drug, which they claimed disincentivizes generic or biosimilar entry and breakthrough innovations, as companies must navigate intellectual property (IP) restrictions during their research and development (R&D) process. However, panelists also noted that generics have spurred increased patent challenges for brand-name companies, and that both innovators and generics use strategies to influence the system. One speaker emphasized that both brand-name and generic companies obtain patents, and that incremental patents play a critical role in driving innovation—arguing that without such patents, there would be no rewarded innovation, and without innovation, no generic industry.
• Restricted distribution systems: Specialty drugs, which account for a growing portion of prescription drug expenditures, are often accessed through limited distribution channels. These systems limit access, cause delays, and allow manufacturers and their contractors to control pricing.
• Pay-for-delay agreements (reverse payments): Brand name companies pay competing generic companies to stay out of the product market, which allows them to share monopoly profits while preventing consumers from having lower-cost alternative drugs. Some panelists encouraged the FTC to open investigations into ongoing business practices that involve such settlements.
• On the federal agency side, Food and Drug Administration (FDA) regulations also impede timely entry of generic and biosimilar drugs into the market. This includes the cost and time of the review and approval process, and strict FDA requirements for generic similarity. Panelists highlighted how stringent requirements on the physical characteristics of the reference listed drug and the generic adds on to challenges for generic entry.

The panelists also discussed potential solutions to address anticompetitive conduct and to improve access to affordable medicines, including:

• Enhancing data sharing and coordination between the FDA and the US Patent and Trademark Office (PTO),
• Reforming the patent review process, including increasing review time for patent examiners and expanding public engagement opportunities to challenge low-quality patents,
• Strengthening the mergers and acquisitions review process and monitoring industry pricing behaviors, and
• Coordinating agency antitrust enforcement to ensure fair competition.

PANEL 2: ANTICOMPETITIVE CONDUCT TO IMPEDE AND REDUCE COMPETITION FROM LOWER-PRICED ALTERNATIVES

Panelists:

• Alex M. Brill, Senior Fellow, American Enterprise Institute
• James Gelfand, President and Chief Executive Officer, The ERISA Industry Committee (ERIC)
• Juliana “Julie” Reed, Executive Director, The Biosimilars Forum
• Jocelyn Ulrich, Vice President of Policy and Research, Pharmaceutical Research and Manufacturers of America (PhRMA)
• Michael A. Carrier, Board of Governors Professor of Law, Rutgers Law School

Panelists were asked about strategies used by brand-name manufacturers to maintain market dominance after generic or biosimilar entry, such as product hopping, rebating strategies, and price fixing. Despite the FDA approving over 70 biosimilars, panelists described a persistent “biosimilar void” driven by a range of anticompetitive practices, pricing mechanisms, and regulatory barriers that prevent significant cost savings for patients and payers. Representatives from BIO and PhRMA pointed to the challenges biosimilar manufacturers face in securing favorable formulary placement and navigating the rebate system. Panelists also underscored the burdens posed by regulatory hurdles and pharmacy benefit manager (PBM)-driven market dynamics. There was broad agreement that policy solutions must balance between encouraging competition and sustaining innovation. Key concerns raised include:

• Rebating strategies by pharmacy benefit managers (PBMs) and the need for PBM reform. Panelists criticized PBMs for being secretive and for hiding claims and accurate pricing data from employers. Several panelists specifically referenced challenges seen from the Humira biosimilars launch, where PBMs continued to push utilization of the higher priced, brand name products to profit from larger rebates. Panelists shared how preference towards brand-name drugs prevent patients from having access to lower-cost alternatives.
• Misuse of the interchangeability designation. Despite no clinical difference between biosimilars and their reference products, some panelists highlighted how misinformation that is often disseminated by brand manufacturers and their proxies persist in confusing providers and patients, limiting uptake of lower-cost biosimilars. Panelists called for increased regulatory oversight into statements and for streamlined biosimilar approval processes.
• Product hopping, where manufacturers reformulate a drug — often with minor therapeutic changes — and then take steps to switch patients to the new version, which impedes generic competition. One panelist noted that there is a greater need for regulations on product hopping in the court system.

The panelists offered several recommendations to address these challenges, including:

• PBM reform, including greater transparency, savings sharing, oversight of formularies, and regulations on business practices,
• Streamlining FDA processes, including eliminating the interchangeability designation and reducing redundant requirements such as 3-way pharmacokinetic (PK) studies that create regulatory and pipeline barriers for biosimilars and generics,
• 340B reform to lower costs and ensure savings benefit patients,
• Addressing challenges in the Inflation Reduction Act’s (IRA) price negotiation provisions that may have chilling effects on innovation or investment, and
• Addressing the high costs of clinical trials to support biosimilar or generic development.