Andrew M. McCoy

Andrew McCoy helps clients grow and protect their intellectual property assets, with a particular focus on intellectual property litigation. He counsels a wide range of clients — from entrepreneurs to Fortune 100 companies — in acquiring, licensing and enforcing patents, trademarks, copyrights and trade secrets; providing due diligence and freedom to operate analysis and opinions; and all aspects of intellectual property litigation. Drew also provides strategic counsel to clients navigating post-grant proceedings, particularly inter partes review (IPR).

View the full bio for Andrew M. McCoy at the Faegre Drinker website.

Articles by Andrew M. McCoy:


FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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