Search Results: test BPCIA and Related U.S. Statutes

Goodwin's Guide to the Biosimilars Patent Dance

Goodwin released today its Guide to the Biosimilars Patent Dance, which lays out in a user-friendly format the complex statutory scheme of the so-called “patent dance” codified in subsection 262(l) of the Biologics Competition and Innovation Act (BPCIA).  The BPCIA’s patent dance dictates a schedule of timed steps according to…

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…

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WSJ Reports on Biosimilar Pricing in the U.S.

Today, the Wall Street Journal published an article by Jonathan D. Rockoff that takes an in-depth look at the actual and expected pricing of biosimilars in the U.S.  For those with WSJ subscriptions, it is well worth a read: http://www.wsj.com/articles/knockoffs-of-biotech-drugs-bring-paltry-savings-1462458209.

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House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…

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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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