Tag Archives: biosimilars

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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Ensuring the Safety and Commercial Success of Biosimilars in the United States

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The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that the FDA and industry should take to ensure patient safety while promoting market competition and continued biomedical innovation. During a presentation Tuesday at the 2014 BIO International Convention, participants at this Super Session focused on the need for prescribing physicians and providers to closely partners with one another to ensure that safety and efficacy are the priorities in the debate Read More >

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BIO Recognizes the Work of Two Indiana Legislators

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Across the country state lawmakers are addressing the issue of biosimilars, lower-cost biologic medicines that stand to benefit severely ill patients combating complex and life threatening diseases. Indiana has been at the forefront of this important issue, and two Indiana state legislators, Representative Ed Clere and Senator Brandt Hershman, were particularly instrumental to the success of biosimilar legislation that was recently signed into law by Governor Mike Pence. Representative Ed Clere (District 72), is Chair Read More >

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