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Keywords: Originators
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Journal Articles
Journal:
Digestive Diseases
Dig Dis (2016) 34 (1-2): 132–139.
Published Online: 16 March 2016
... expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce...