Tag Archives: Biologics

WSJ: U.S. Concessions on TPP Means Fewer Cures

Seal of the President of the U.S.

Today’s Wall Street Journal editorial, Pacific Trade Brinksmanship, does an outstanding job highlighting the important role that patent protection plays in promoting innovation and fostering medical breakthroughs. The article highlights why adequate protections for biologics must be a centerpiece of a successful Trans-Pacific Partnership (TPP). One of the issues being negotiated is the right amount of patent protection for innovative medicines. As the editorial notes, the U.S. currently wants “biologic protections to last a dozen Read More >

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New Report Suggests RDP Does Not Increase Healthcare Expenditures

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A new paper by the Geneva Network suggests that increasing the period of regulatory data protection (RDP) for biologic medicines would not increase expenditures for medicines. As countries navigate the final negotiations in the Trans-Pacific Partnership, the U.S. and Japan have advocated for increased regulatory data protection for biologic medicines by other TPP countries. In the U.S. biologics enjoy 12 years of data exclusivity; the only TPP countries, aside from the U.S, offering more than Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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Updated Legal and Regulatory Frameworks Needed for Biosimilars

Jim Greenwood

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. We call on the FDA to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological. There has been positive momentum recently, however, we believe the appropriate way to develop policy on such Read More >

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Pitts Sounds off on Biosimilar Naming

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This week, the Food and Drug Law Institute published a white paper – Biosimilar Nomenclature: Can we achieve the truth, the whole truth, & nothing but the truth? – outlining key considerations around the naming of biosimilars. Peter J. Pitts, President, Center for Medicine in the Public Interest and Former Associate Commissioner, US Food and Drug Administration, asserts that ‘those who view distinctive biosimilar nomenclature naming as either contrary to safety or anti-competitive are addressing Read More >

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