The Generics Bulletin Podcast: 2026 Conferences

Well, hello, and welcome to the latest episode of the Generics Bulletin podcast. I'm Dame Rudge, deputy editor of Generics Bulletin. And today, I'm very happy to be joined by Dave Wallace, the editor of Generics Bulletin. And Ortega Fortunovicidesen, your reporter. On today's episode, we'll be discussing two major industry events that happened at the February, both of which helped to offer a window into where the global generics and biosimilar sector is heading. The first event is the Access twenty twenty six annual meeting organized by the US Association for the Accessible Medicines in Miami and attended by Dave. This brought together policymakers, industry leaders, and commercial experts to talk about the business and political forces shaping The US generics and biosimilar market, examining for one the current environment on Capitol Hill just over a year into the second Trump presidency. The other event took place in Amsterdam where Earte heard regulators, companies, and policy specialists gathered for the regulatory and scientific affairs conference organized by Medicines for Europe. This event focused on the rapidly evolving regulatory landscape in Europe, including the plan revision of the EU's pharmaceutical legislation, which represents one of the biggest updates to the regulatory framework in roughly two decades. Between them, these meetings touched on everything from market trends and supply chains to regulatory reform, digitalization, and the future of access to medicines. Dave and Earte have already provided expert written coverage of certain aspects of the conferences, and I'd encourage listeners to head to the generic bulletin website to read these if they haven't done so already. So, Earte, let's start in Amsterdam. What were the key themes, ideas, and talking points at the Regulatory and Scientific Affairs Conference? Yeah. So I think the biggest, and the most anticipated topic this year was the formal legislation. Since the and since the conference, the EU regulators already agreed on the final version of the draft pharma reform package, which includes both the new directive and regulation for governing pharmaceutical products in the region. The formal adoption is anticipated to start in the second quarter of this year, so very much anytime soon. And those legislation will start coming into force this summer, but there will be a two year transition period, meaning that not every provision will be applied until the full implementation deadline, which is, I think, scheduled for summer twenty twenty eight. And, yeah, this will be a massive change. The current regulatory framework has been in place for twenty years. So naturally, the industry had questions on what should be prioritized first, as many do anticipate that complying with new regulatory changes will require time, updates to internal processes, and investments. However, the regulatory speakers and representatives didn't have many answers themselves. But as medicines for Europe's regulatory head, Beata Stepanescu, told me at the silence of the conference that the devil will be in the details in terms of practical implementation and guidelines, and the next two years will …