The final day of GRx+Biosims was a rewarding day of excitement for all participants. If Day 1 was about passion and purpose, and Day 2 about putting that passion into practice, Day 3 delivered on the promise of progress. It was a milestone day – one that united leadership, science, and policy in tangible action. By its close, attendees left not just inspired but witnessing the tangible manifestation of their collective efforts and commitment.
Leadership and Optimism: Keren Haruvi’s Call to Action
AAM Board Chair Keren Haruvi, President of Sandoz North America, opened the final morning with a message of unity and conviction. Her tone was equal parts gratitude and resolve, celebrating how far the industry has come while challenging it to go further still.
“We are united by a singular mission,” she began, “to ensure that every patient has access to the medicines they need. This is at the heart of everything we do.” It was both a reflection on shared purpose and a call to action for the years ahead.
Haruvi’s remarks blended optimism with specificity. She praised the Administration’s recognition of generics and biosimilars as a distinct pillar of the health-care economy and commended the decision to exempt them from new tariff regimes. But she also warned that progress must be codified.
“We look to the future with optimism knowing that codifying tariff exemptions for our products is more than a policy win – it is a statement that access to safe, effective, affordable medicines is a national priority and a priority of this Administration,” Haruvi said. “This is also a testament to what is possible when we stand united, guided by science with a shared sense of purpose and a clear message: healthcare advancements and patient access must go hand in hand.”
She spoke candidly about systemic barriers: patent abuse, unnecessary regulatory complexity, and PBM practices that still limit competition. “It’s simple economics—competition lowers costs,” she said.
Keren Haruvi concluded her comments setting the stage for the industry and calling on participants to redouble their commitment. Her optimism was forward-looking: a vision of a biosimilar marketplace that is robust, transparent, and sustainable. “This is our moment to act – to build a health-care system that puts patients first, fosters innovation, and unlocks the full promise of generics and biosimilars for every American,” she said in closing. The energy in the room was palpable.
Standards, Trust, and the Next Era of Collaboration
Following Haruvi, AAM President and CEO John Murphy sat down with USP CEO Ron Piervincenzi for a fireside conversation that reinforced one of the conference’s most consistent refrains: collaboration is the new competitive advantage.
Piervincenzi described USP’s modernized standards as “a living framework for quality,” one built in partnership with FDA and industry to improve predictability and speed approvals. He shared how new digital systems and data-sharing efforts are already cutting through uncertainty.
“Standards and surprises don’t go together,” he said. “The more transparency we build in, the stronger the entire ecosystem becomes.”
Murphy underscored that alignment between AAM, FDA, and USP has never been stronger – something tangible in the conference’s strong attendance by FDA staff. For attendees, it was an encouraging glimpse of regulatory and standards bodies pulling in the same direction to accelerate access without sacrificing safety.
A Milestone Moment: FDA Commissioner Marty Makary’s Announcement
Then came the day’s defining moment. In a fireside chat with John Murphy, FDA Commissioner Dr. Marty Makary confirmed rumors that had been growing throughout the week: the agency would issue new guidance on comparative efficacy study requirements for biosimilar approval and advance a universal interchangeability framework.
“We need more biosimilars on market. We need to cut the red tape for biosimilars and we need to recognize that biosimilars have the promise of lowering drug prices, a major priority in this administration and improving access for patients who otherwise can’t get access.”
The announcements electrified the room and elicited standing ovations. Makary explained that the FDA’s new draft guidance would cut biosimilar development timelines, reduce costs, and fast-track applications for U.S.-made biologics as part of a domestic-manufacturing incentive.
Makary tied the move to a broader “America First” agenda emphasizing affordability, national security, and public trust. He said, “If a biosimilar is going to be made in the United States of America, it’s going to go to the front of on the line. We believe in domestic manufacturing as a national security issue.”
Makary concluded, “We want to ignite a very robust marketplace for biosimilars, a marketplace we’ve never seen before. We only have 76 FDA approved biosimilars in the United States, it should be two or three times higher.”
The HHS Press Conference: From Vision to Policy
By early afternoon, those words became policy. At a HHS press conference led by Secretary Robert F. Kennedy Jr., the administration formally unveiled its biosimilar reform initiative – a plan to reduce regulatory barriers and accelerate market entry. Kennedy denounced the rules of the past. Under the new framework there would be more competition, lower prices, and faster access to life-saving medicines.
Standing beside him, Makary expanded on the technical reforms, noting that the guidance would remove costly comparative studies and align interchangeability standards with generics. “This reform will take the five-to-eight-year time frame to bring a biosimilar to market and cut it in half. It will also save companies about a hundred million dollars in their development costs. That’ll take the cost down from 200 million down to 100 million or 250 million down to 150 million.” he said.
CMS Administrator Dr. Memet Oz singled out the Association for Accessible Medicines by name. “How many of you have heard of that group?” he asked reporters. “They gave Marty three standing ovations today. That doesn’t happen in academic circles.”
Closing Reflections: More than a Moment – A Movement
Across three days, GRx+Biosims 2025 had traced an arc from passion to purpose to progress. Day 1 reminded everyone why the community exists. Day 2 demonstrated how it works. And Day 3 showed what happens when science, policy, and leadership converge in the service of patients.
As attendees filed out for the farewell luncheon, the consensus was unmistakable: this was the conference when the biosimilars movement came of age—when advocacy met action, and “bringing more medicine to more people” became not just a theme, but a tangible reality.
