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Nelson Mullins COVID-19 Resources

Nelson Mullins is continuing to monitor developments related to COVID-19, including guidance from the Centers for Disease Control and various federal, state, and local government authorities. The firm is taking appropriate precautionary actions and has implemented plans to ensure the continuation of all firm services to clients from both in office and remote work arrangements across our 25 offices. 

In addition, click the link below to access extensive resources to address a wide variety of topics resulting from the virus, in general and by industry,  including topics such as essential businesses, force majeure, business interruption insurance, CARES Act and FFCRA, and others. 

Nelson Mullins COVID-19 Resources

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May 14, 2020

Nine States Sue EPA Over Temporary COVID-19 Enforcement Policy

In the News

April 1, 2020

Biosimilars Tackle Interchangeability Standards

BioPharm International

In an article published in BioPharm International, Columbia partner Jennifer Mallory discusses the biosimilars interchangeability and the many evaluation and testing requirements that are needed to ensure compliance and safety.

“These are designed to ensure that the biosimilar produces the same clinical result as the approved biologic in any patient and that the safety and efficacy risks arising from switching between the approved biologic and the biosimilar are not greater than the risk of using just the approved biologic,” Mallory says.

An important theme in the guidance, Mallory emphasizes, is that FDA is not suggesting that there is a one-size-fits-all approach for demonstrating interchangeability. Rather, the agency used the guidance to confirm that demonstrating interchangeability is complex, much like the complex molecules involved. “Thus, FDA noted in the guidance that the ‘data and information necessary to support a demonstration of interchangeability need to be considered on a case-by-case basis.’,” Mallory says.

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