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Bioequivalence of Follow-on Biologics or Biosimilars

Author(s): Yellela Sri Rama Krishnaiah

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 01;
Issue: 02;
Start page: i;
Date: 2009;
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The patents for a large number of the first generationbiopharmaceutical drugs or biologics are getting expired, and thus opening the doors for generic competition. It is a fact that these biopharmaceutical drugs have become an important part of pharmacotherapy in treating the so-called incurable or orphan diseases such as cancers and genetic diseases. However, these miracle drugs are highly expensive adding a lot to the health-care costs. At the same time, the blockbuster status of these biologics driving several generic drug manufacturers and large pharmaceutical industries to produce follow-on biologics or biosimilars. The term “follow-on biologics (FoB)” is used in United States while the term “biosimilars” is used in the European Union. Over a dozen biosimilars are approved across the world, mainly in Europe.
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