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FDA Basics Webinar August 19, 2013: Biological Products, Part 2: Biosimilar Biological Products

Many of today’s important medications are biological products, generally derived from living material from humans, animals, or microorganisms.  These products treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, and various forms of cancer.  Unlike other drugs known as small molecule drugs, biological products are generally highly complex in structure. 

Part one of this two-part series, presented June 17, 2013, provided an overview of biological products and how they differ from small molecule drugs.  This webinar (part two) addresses “biosimilars.”  A biosimilar is a biological product that is similar to or interchangeable with another FDA-approved biological product.  In 2010, the Obama Administration passed the Biologics Price Competition Innovation Act, designed to encourage the development of biosimilar biological products which can enhance competition and may lead to better patient access and lower cost to consumers.
 

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