Tag Archives: Biologics

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

Jim-044

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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Spotlight on China

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The 20th annual BIO International Convention is wrapping up in Chicago. Experts and leaders from leading global biotechnology, biologics and investment companies gathered together to discuss the opportunities and challenges in the biologics industry. A large China Food and Drug Administration (CFDA) delegation led by Deputy Commissioner Bian Zhenjia participated in a half-day session dedicated to developing a world-class therapeutic biologics industry in China. There has been a shift in recent years in the usage Read More >

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Despite Low Funding, Biotech Productivity Remains High In 2013

John Milligan

At the 2013 BIO CEO & Investor Conference, John Milligan, President and COO of Gilead Sciences, spoke in a standing room only fireside chat with Joel Sendek, Managing Director of Stifel Nicolaus, who moderated the discussion. Nicolaus noted that Gilead’s market cap has grown at an astounding 40 fold over the past 15 years, and asked Milligan to speak about the current state of the biotech industry. Milligan explained that biotech is not becoming more Read More >

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