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Biosimilars Development Roundup for October 2024—Podcast Edition
On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Show notes
1. Jeremias S. Strengthening the supply chain: key insights from FDA commissioner Dr Robert Califf. The Center for Biosimilars®. October 25, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/strengthening-the-supply-chain-key-insights-from-fda-commissioner-robert-califf
2. Jeremias S. FDA and industry experts unpack biosimilar device requirements. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/fda-and-industry-experts-unpack-biosimilar-device-requirements
3. Jeremias S. Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/calling-for-unified-biosimilar-standards-stronger-education-at-grx-biosims
4. Jeremias S. Unifying standards: the need for streamlined biosimilar development. The Center for Biosimilars. October 22, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/unifying-standards-the-need-for-streamlined-biosimilar-development
5. Jeremias S. Enhancing Adoption of Infused Biosimilars for a Sustainable Future. The Center for Biosimilars. October 30, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/enhancing-adoption-of-infused-biosimilars-for-a-sustainable-future
6. Jeremias S. IQVIA webinar: enhancing regulatory strategies for biosimilars and generics. The Center for Biosimilars. October 14, 2024. Accessed November 1, 2024. https://www.centerforbiosimilars.com/view/iqvia-webinar-enhancing-regulatory-strategies-for-biosimilars-and-generics
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
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?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
