AAM
Despite recent wins on streamlining and interchangeability, the US biosimilars industry continues to face challenges such as IRA price negotiation, dysfunctional pricing dynamics and PBM distortions, says AAM Biosimilars Council chief Alex Keeton.
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
At the AAM’s Access! 2026 conference, a dedicated panel on the latest developments for biosimilars discussed challenges and opportunities in the US market, predicting consolidation among current players as well as calling for policies that put biosimilars first.
Generics Bulletin editor Dave Wallace joins Pink Sheet editors to discuss the generics and biosimilars industries’ priorities following the recent AAM Access! 2026 conference, as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.
During a candid and revealing discussion, lobbying experts shared trade secrets with the AAM’s Access! 2026 conference on how to get the generics and biosimilars industry’s message heard by lawmakers, as well as looking ahead to the importance of upcoming US midterms.
As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’
AAM president and CEO John Murphy summarized a year of progress for the off-patent industry in front of an audience of generics and biosimilars industry delegates at the AAM’s Access! 2026 annual conference – but also said more efforts were needed to create a sustainable future environment.
As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.
In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.
A new US presidential administration brings both challenges and opportunities for the off-patent industry. Speaking to Generics Bulletin on the sidelines of the AAM’s annual conference earlier this month, the association’s chair and Sandoz North America president Keren Haruvi discusses how the group plans to make its voice heard on key priorities including tariffs, PBM reform, and regulatory streamlining.
Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
At a lively AAM Access! conference in Florida this week, the latest actions taken by Donald Trump ranked high on the agenda. But as well as acknowledging the negative effects of potential tariffs, the AAM’s president and CEO John Murphy also suggested that the advent of the second Trump administration could offer an opportunity for the generics and biosimilars sector to make its voice heard on proposed market reforms.
Generics Bulletin previews the most noteworthy and anticipated events for February 2025.
Principal deputy director of the US FDA’s Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, used part of her 20-minute keynote address at the recent AAM Access! annual conference to focus on drug shortages that persist across the US.
The AAM’s annual Access! 2024 conference brought its much-enjoyed CEOs Unplugged panel to Tampa again for another engaging discussion on critical issues, challenges and opportunities for generics and biosimilars in the US.
Dramatic downward pressure on prices will continue to impact supply for an industry already reeling from shortages, the Association for Accessible Medicines’ newly appointed chair Keren Haruvi tells Generics Bulletin during an exclusive interview on the sidelines of the association’s recent annual conference in Tampa.