Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines

Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD

Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree […]

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