"Not So Different:" A Regulatory Attorney Shares His Take on Interchangeability

Podcast

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.

Related Videos
Prerakkumar Parikh, PharmD
Cencora's Corey Ford
Brian Biehn
GBW 2023 webinar
Fran Gregory, PharmD, MBA
Fran Gregory, PharmD, vice president of emerging therapies, Cardinal Health
Here are the top 5 biosimilar articles for the week of May 1, 2023.
Christine Baeder
Here are the top 5 biosimilar articles for the week of February 13th, 2023.
Michael Kleinrock
Related Content
© 2024 MJH Life Sciences

All rights reserved.