Unlocking Biosimilars in the US: Regulatory Paths to Wider Access
Writing in the January 2026 edition of DIA Global Forum, Mariana Socal and Antonio J. Trujillo from the Johns Hopkins Bloomberg School of Public Health and Rachel Goode of Fresenius…
Bristol Myers Squibb (BMS), faced with patent expiries for its two largest historical revenue-generators, is racing to replace them. The US giant is re-entering the hot-again neuroscience space, as well as bringing forward cardiovascular, immunology, and oncology molecules, with management…
Writing in the January 2026 edition of DIA Global Forum, Mariana Socal and Antonio J. Trujillo from the Johns Hopkins Bloomberg School of Public Health and Rachel Goode of Fresenius…
Cardiff Advisory’s David H. Crean outlines how the 2026 JP Morgan Healthcare Conference signaled a shift from sector reset to disciplined re-acceleration in global biopharma. Dr Crean explores investor sentiment,…
John Murphy III, President and CEO of the Association for Accessible Medicines (AAM), argues that 2026 represents a pivotal moment for the United States to reclaim leadership in biosimilars. He…
Paul Kim, a leading FDA attorney and policy expert formerly at both the FDA and the US Congress, discusses the current shifts within the American life sciences and regulatory landscape.…
After 25 years at Genzyme and Sanofi, Chris Hwang joined a biotech startup in China in 2016 to develop advanced bioprocessing technologies that reduce cost of goods while maintaining reliable…
Kim Moran, SVP & Head of US Rare Disease at UCB, discusses how the company is building on its long-standing heritage in neurology to expand into rare and ultra-rare conditions.…
Jerry Radich of the Fred Hutchinson Cancer Center, writing in the February 2026 edition of DIA’s Global Forum magazine, lays out a framework for taking cutting-edge cancer therapies – currently…
2025 was a year of volatility for pharma and healthcare. In particular, the speed with which the administration of Donald Trump makes (and often then changes) consequential policy decisions has…
2026 could mark a turning point for biosimilar adoption in the US. By scrapping requirements for redundant clinical trials and pushing Congress to end the “Interchangeable” label, the FDA has…
Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the…
Healthcare is finally moving from a reactive “machine” to a proactive shield. In the latest issue of ISPOR’s Value & Outcomes Spotlight, Editor-in-Chief Zeba M. Khan, PhD, examines how Real-World…
ISPOR’s Rob Abbott traces AI’s evolution in healthcare from early expert systems to today’s machine learning and large language models, arguing that AI is now central to health economics and…
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