Tag Archives: Biologics

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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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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Delivering the Right Dose, Less Often

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Biologics are a growing area of drug development, including life-threatening and life-changing disorders such as cancer and rheumatoid arthritis. However, many biologics have short half-lives, and need to be dosed daily. To make them more convenient to use, as well as safer and more effective, researchers are developing delivery systems that keep the biologics in the body for longer, reducing the frequency of dosing. Swedish company Affibody is using the natural affinity of a naturally-occurring Read More >

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FDA Week: For Biologics, A Name Isn’t Just A Name (Jim Greenwood op-ed)

Jim Greenwood

What is in a name? Names help make medicinal products more easily distinguishable by doctors, pharmacists and patients. When you are talking about biologics, complex medicines that are manufactured using living organisms, and biosimilars, medicines that are similar to, but not the same as, innovator biologics, naming is a significant consideration. As a pathway for biosimilars approval is implemented, a clear priority should be to craft a naming convention that both contributes to patient safety Read More >

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