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"Not So Different": A Look Ahead to Biosimilar Insulin
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.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
