Search Results: Biosimilar News

BREAKING NEWS: Deal Is Reached on TPP

It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP). As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to…

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Impending TPP Agreement's Potential Impact on Biologics

On June 23, 2015, the U.S. Senate authorized President Obama to negotiate on a “fast-track” basis the Trans-Pacific Partnership agreement (TPP).  TPP is a proposed trade agreement between several pacific countries concerning a variety of matters, including intellectual property and pharmaceutical products.  Negotiations over TPP, which have been taking place…

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Biologics, Biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”): A Short Primer

Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues. What are biologics? Biologics are medical products such as vaccines, therapeutic proteins, and gene therapies that…

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