Conferences
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.
Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.
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.
In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.
Europe is facing one of the biggest pharmaceutical reforms in two decades. Medicines for Europe’s Beata Stepniewska and Adrian van den Hoven outlined how the regulatory trinity – EU pharmaceutical legislation, Critical Medicines Act, and Biotech Act – will reshape the industry.
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.
At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.