GRx+Biosims is November 2–4 in Rockville MD: Here’s Why You Should Attend
By Ashley Henyan, Communications Director, AAM
If your work impacts America’s patients in any way, chances are you’ve previously attended AAM’s GRx+Biosims Conference. This makes sense. Generic and biosimilar medicines impact nearly ALL patients in the United States. In fact, the off-patent medicines industry is directly responsible for nearly 90% of every prescription filled in America—that’s four billion prescriptions picked up from pharmacies and placed into medicine cabinets last year alone. Add to that the generic and biosimilar medicines industry is the ONLY sector of healthcare consistently lowering costs, year-over-year, for American patients and the importance of leaders across the manufacturing, legal, regulatory and policy spaces coming together to ensure a future for generics and biosimilars makes even more sense.
If you are on the fence about attending GRx+Biosims this year, climb down—then brush off your trousers and click here to register before it’s too late!
AAM is pleased to welcome Kyle Diamantas, J.D., Acting Commissioner of Food and Drugs, to the GRx+Biosims mainstage, this year. Diamantas will participate in a keynote fireside chat that you won’t want to miss.
On November 4, 2026, Diamantas will sit down with AAM Board Member, Maryll Toufanian, of Amneal Pharmaceuticals to share perspective on issues affecting the generic and biosimilar medicines industry today, as well as insights into the regulatory landscape of tomorrow. Combined, Diamantas and Toufanian have decades of experience in the regulatory, policy, legal, compliance, and legislation spheres—and will surely provide insights into a vast array of topics. This fireside chat is the perfect recipe for an engaging GRx+Biosims mainstage exchange. And we know it will leave attendees motivated and inspired for what’s ahead as we all look to the future of generic and biosimilar medicines, together.
In addition to hearing from the Acting Commissioner of Food and Drugs, for the first time in years, ALL CDER Leadership directly impacting the generic and biosimilar space will not only be in attendance, but will all also be delivering mainstage keynote addresses. GRx+Biosims 2026 attendees will hear from Iilun Murphy, MD, Director, Office of Generic Drugs, CDER; Sarah Yim, MD, Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER; Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality (OPQ), CDER; Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations, OII; and Jill Furman, JD Director, Office of Compliance, CDER.
“It’s been very exciting collaborating with AAM’s members and our events team to plan this year’s conference,” said Scott Kuzner, Senior Director of Sciences & Regulatory Affairs for AAM. “You’ll get to hear the latest information on the intersection of policy, science, and regulatory affairs, and learn how it all relates to advancing patient accessibility through purposeful and science-based actions. And this year we are having a supersized selection of breakout sessions – over 15 breakout sessions will be available throughout our three-day event.”
One of those breakout sessions will focus on how evolving quality approaches and regulatory flexibility can support more resilient generic and biosimilar supply chains while maintaining product quality, safety, and compliance. The session also aims to explore broader quality and supply solutions that may strengthen supply reliability for generic and biosimilar medicines. The session, titled The Future of Quality and Supply: Site Transfers and Manufacturing Resilience, will be moderated by Kristin Willemsen, MSc, Vice President of Scientific & Regulatory Affairs for the Canadian Generic Pharmaceutical Association.
“The future of quality and supply is a global issue that is gaining a lot of attention by policy makers and healthcare system partners,” Kristin Willemsen said. “Moderating this panel, as an international industry representative, says a lot about the interests of attendees and the depth and breadth of this event. I’m looking forward to how our conversation unfolds on how regulatory flexibility can support more resilient supply chains while maintaining product quality.”
Beyond information sharing, learning and networking, AAM events always offer opportunities for attendees to have a little fun. This year, attendees can step into an evening where science meets celebration at the official GRx+Biosims 2026 Dinner. While our events team always keeps a few surprises up their sleeves, especially when it comes to the entertainment portion of the evening, we know the USP house band, The Impurities, will be onsite to deliver a much anticipated performance featuring rock-and-roll, punk, country, and pop favorites spanning decades—and a few originals of their own, too!
The GRx+Biosims Expo is another draw, with around 20 booths registered to allow for one-on-one scientific-level interactions across sectors to help increase broader understanding.
