The second and final day of Access! 2025 reinforced the urgency of addressing the challenges facing the generics and biosimilars industry. Amid growing political scrutiny, regulatory uncertainty, and shifting market dynamics, speakers and panelists highlighted the industry’s vital role in ensuring access to affordable medicines. From biosimilar adoption and PBM reform to FDA regulatory risks and evolving policy landscapes, the discussions over the past two days underscored the need for industry unity and strategic engagement to drive meaningful change.
AAM’s Vision for 2025: Meeting the Moment
AAM President and CEO John Murphy III opened the day by reflecting on the discussions from Day 1 and the path forward. He emphasized that while challenges persist, the industry has an opportunity to shape policy, expand access, and strengthen competition. With a new administration and Congress poised to take action on healthcare issues, Murphy stressed the importance of proactive engagement and coalition-building to ensure generics and biosimilars remain central to drug pricing reform.
Fighting for a Sustainable Future
AAM Board Chair Keren Haruvi, President of Sandoz North America, delivered a keynote address that focused on the industry’s role in maintaining affordability and access to medicines. She highlighted the critical role of generics and biosimilars, which account for 90% of prescriptions but just 13% of total drug spending, yet continue to face economic and regulatory headwinds.
Haruvi pointed to growing bipartisan recognition in Washington that pricing policies and PBM practices have created an unsustainable market, contributing to drug shortages and limiting competition. Looking ahead, she emphasized that 2025 presents a crucial opportunity to build on recent momentum by focusing on four key priorities: addressing drug shortages, driving PBM reform, advancing patent litigation reforms, and streamlining biosimilar regulatory pathways. She called on industry leaders to align with policymakers, patient advocates, and employers to drive these critical changes.
Honoring a Lifetime of Leadership
A highlight of the morning was the presentation of AAM’s Lifetime Achievement Award to Bob Pollock of Lachman Consultant Services, recognizing his decades of contributions to the generics industry. Reflecting on his career, Pollock recalled how the Hatch-Waxman Act transformed access to affordable medicines and reinforced the importance of competition in driving affordability. He urged the industry to remain vigilant in defending and strengthening the framework that has allowed generics to thrive.
Biosimilar Adoption: A PBM Perspective in a Time of Scrutiny
With PBMs under heightened scrutiny for their role in prescription drug costs, the fireside chat featuring Craig Burton, Executive Director of the Biosimilars Council, and Joshua Fredell, Senior Vice President at CVS Health, provided insight into biosimilar adoption strategies from a PBM perspective.
Fredell discussed how PBMs must balance the needs of employers, government payers, and health plans while managing cost pressures. He pointed to CVS Caremark’s private-label strategy for adalimumab as a major development in the biosimilar space, demonstrating how vertically integrated models can create price competition and ensure continuity of supply.
However, he acknowledged that biosimilar adoption remains complex, requiring PBMs to navigate rebate structures, formulary preferences, and physician prescribing behaviors. While PBMs play a role in reducing costs, Fredell stressed that achieving widespread biosimilar uptake requires collaboration across manufacturers, insurers, and policymakers.
A Conversation with Former HHS Secretary Alex Azar
In a fireside chat with John Murphy III, Former HHS Secretary Alex Azar provided a candid perspective on the evolving policy landscape and the role generics and biosimilars play in drug pricing reform. Azar emphasized that President Trump is personally committed to lowering drug prices and views generics and biosimilars as essential to achieving that goal.
Throughout the discussion, Azar reinforced the industry’s critical role in delivering cost savings and expanding patient access, noting that policymakers recognize generics as “the good guys” in the healthcare debate. He urged industry leaders to engage directly with the administration to ensure policies support a competitive and sustainable pharmaceutical market.
Scott Gottlieb on FDA Challenges and Regulatory Risks
Former FDA Commissioner Scott Gottlieb joined Murphy to discuss growing concerns about changes at the FDA. Gottlieb stated that he is “exceedingly worried” about how proposed personnel changes and policy directives could impact public health and regulatory efficiency. He pointed specifically to a buyout program that could result in the loss of 3,000 FDA staff members, potentially leading to slowdowns in critical agency operations. Gottlieb highlighted user fee negotiations as one key area that could be adversely impacted by personnel departures.
He also raised concerns about a recent Office of Management and Budget (OMB) directive, requiring that for every new regulation issued, ten must be retracted. Gottlieb warned that this policy could also impede key processes and initiatives. Without careful implementation, these changes could lead to significant delays and inefficiencies in agency operations and ultimately impact public health priorities.
CEOs Unplugged: Leading Through Uncertainty
The conference concluded with a CEO panel featuring Vinita Gupta (Lupin), Chirag Patel (Amneal), and Richard Saynor (Sandoz), moderated by Scott Gottlieb. The discussion provided a candid look at how leading pharmaceutical companies are adapting to downward pricing trends, regulatory challenges, and supply chain disruptions.
The panelists emphasized the need for manufacturers to rethink market strategies, embrace innovation, and build strategic partnerships to remain competitive. While challenges persist, they underscored the resilience of the generics and biosimilars industry, highlighting that despite economic pressures, its role in ensuring affordable access to medicine has never been more critical.
AAM’s Call to Action: Turning Momentum into Policy Change
In his closing remarks, John Murphy III urged attendees to take the momentum of Access! 2025 and translate it into policy victories and market reforms. With new political leadership and heightened public focus on drug pricing, he emphasized that this is the time for the industry to push for solutions that ensure a sustainable market for generics and biosimilars.
While challenges remain, Murphy reminded attendees that the past two days demonstrated the industry’s ability to come together, engage with policymakers, and shape the national conversation on healthcare affordability. The bipartisan focus on PBM transparency, regulatory efficiency, and supply chain stability signals that generics and biosimilars are at the center of the healthcare policy debate.
As the conference came to a close, one key theme stood out: the fight for affordability, access, and sustainability is far from over. But with a unified voice and strategic leadership, the generics and biosimilars industry is positioned to drive meaningful reform in the year ahead.
Access! 2025 reinforced that now is the time for action.
