Tag Archives: Biologics

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)

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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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BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

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Industry Growth Factor: Biologics

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Last week, EvaluatePharma released their updated sales and R&D outlook for the drug industry in their report “World Preview 2013, Outlook to 2018”. Among the 37 pages of data, one central take home message was that growth will return to the sector after a small dip in 2012. Behind this predicted comeback in sales growth is the rise of biologics products that continue to gain a larger percentage of total revenue. Consider the data below taken from Read More >

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