This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.
Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them.
This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.
Read more about the interchangeability guidance here.
Learn more about the upcoming transition here.
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February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
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December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
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