Staburo supported Neulasta® biosimilar development (Pelmeg®)
Together with Cinfa Biotech GmbH (now Mundipharma Biologics) and the University of Lucerne, Staburo recently published the first part of the results for Pelmeg®, a biosimilar for Neulasta® which is used for preventing neutropenia, induced by chemotherapy (click here to read the whole article DOI: 10.1002/prp2.503). As part of the collaboration, Staburo Principal Statistician and Managing Director Josef Höfler supported the interdisciplinary team with biostatistics expertise, especially in PK/PD.
The team planned, conducted and analysed a single dose, randomized, double-blind, two-way crossover study and demonstrated the comparability for the two PK endpoints examined (area under the concentration curve from time zero to last measurable concentration and the maximum concentration). The PD comparability (area under the effect curve for absolute neutrophil count [ANC]) was demonstrated, as well. The team could show that there are clinically no differences between Pelmeg® and Neulasta® with regard to immunogenicity and safety. Pelmeg® was approved as a pegfilgrastim biosimilar in Europe.