Tag Archives: biosimilars

FDA Acts on Biosimilars

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The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming 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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Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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