All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

Season 7, Episode 6,   Nov 30, 03:00 PM

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In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on clinical efficacy testing and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here.
To read more about G's discussion with Sarah Yim, MD, from the FDA from the recent 2025 GRx+Biosims conference, click here.
To read more on Yim's perspectives on biosimilar policy harmonization, click here.