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

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 […]


Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to treat chemotherapy-induced neutropenia. Professor Dr Gascón discussed ’perspectives of pegfilgrastim’ and Dr Roth and Dr Jankowsky discussed why biosimilars are vital for oncology care. Submitted: […]