A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006)
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DOI: 10.1080/03007995.2022.2061707
Abstract: Abstract Objective The totality-of-evidence approach requires that similarity between a proposed biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical, and clinical parameters to establish biosimilarity. We describe the totality of… read more here.
Keywords: reference biologic; reference; pegfilgrastim; totality evidence ... See more keywords