Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we catch up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shares his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.
Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we catch up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shares his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.
Learn more about transition products, the recently issued interchangeability guidance, and suffixes.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
October 14th 2024During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.