TBLA provides the following publications and articles as part of our commitment to providing a clear summary of news and laws, and their impact on business and business strategies. If you have questions about any of these topics or would like to discuss them further, please feel free to contact us.

The Inevitability of Interchangeability (updated Fall 2013)

Quick Reference Guide: United States Patent and FDA Regulatory Pathways for Small Molecule and Biologic Drugs (updated Fall 2012)

Business Implications of the 2011 Leahy-Smith America Invents Act (Fall 2011)

The United States Patient Protection and Affordable Care Act of 2010: How Advances in Bioanalytics Might Cloud FDA Approval of Follow-On Biologics (Winter 2010-2011)

The Patient Protection and Affordable Care Act of 2010: The Meaning of “Related Entities” [TBLA's presentation at United States Food & Drug Administration (FDA) regarding Biosimilars] (Fall 2010)

The United States Patient Protection and Affordable Care Act of 2010: Clarifying “Exclusivity”, “Evergreening” and “Related Entities” Terminology (Fall 2010)

United States FDA Approval Of Generic Lovenox®: A First Glimpse At Follow-On Biologic Sameness (Summer 2010)

The United States Patient Protection and Affordable Care Act of 2010: Perils of Mandatory Pre-Litigation Disclosure of Confidential Information (Summer 2010)

* These publications and articles may be reproduced in whole or in part so long as credit is given to the authors.