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For biosimilar developers, the equivalent analysis focuses on the 351(k) landscape: reference product exclusivity expiration dates (which establish the earliest possible FDA approval date), the biosimilar patent dance posture (whether to engage or opt out), and the competitive field of other biosimilar developers targeting the same reference product
research-chemical
Dosis:5 mg
[DOI] [PubMed] [Google Scholar] 51.Meier JJ, et al
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