Transcription of An Analysis of the US Biosimilars Development …
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An Analysis of the US Biosimilars Development …
B i o s i m i l a r s MARKETS. An Analysis of the US Biosimilars Development Pipeline and Likely Market Evolution by Ronald A. Rader N. o consensus concerning Table 1: Percentage of reference products biosimilar-related with patents expiring after market and data terminology and definitions exclusivity expirations has yet been achieved (1 3). Patents United European Biosimilars may be defined as Expire After States Union biopharmaceuticals slated for generic- Data exclusivity 87% 86%. drug like, abbreviated, (12 years) (10 years). comparisons-based approvals through Orphan 96% 96%. exclusivity (7 years) (10 years). a formal biosimilar approval pathway in the United States, European Union, and/or other highly regulated and Biosimilar markets in other developed countries based on a countries , Canada and Japan demonstration of substantial (bio) also are small parts of the big similarity to a reference product.
16 BioProcess International 11(6)s Ju n e 2013 Supplement N o consensus concerning biosimilar-related terminology and definitions has …
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