Mundipharma Launches Biosimilar Pegfilgrastim in Germany, the Netherlands, and Ireland

Mundipharma announced today that it has launched Pelmeg, a biosimilar pegfilgrastim referencing Neulasta, in Germany, the Netherlands, and Ireland.

“We are delighted that Pelmeg is now available in these countries,” Philippe Bastide, Mundipharma’s head of biosimilars, Europe, said in a statement. “The launch of the treatment builds on our proven commercial excellence in biosimilars over the past 4 years. Pelmeg has the potential to play an important role in improving the lives of patients affected by chemotherapy-induced neutropenia and febrile neutropenia,” he added.

Pelmeg, which was developed by Cinfa Biotech, was authorized by the European Commission in November 208 following a positive recommendation from the Committee for Medicinal Products for Human Use in September 2018. The biosimilar gained a positive recommendation on the basis of a comprehensive package of data including a comparability study of pharmacodynamics (PD) and immunogenicity that was presented at the American Society of Hematology’s annual meeting in December 2017.

The study¹ was a multiple-dose, randomized, double-blind, 3-period, 2-sequence cross-over study in 96 healthy volunteers. During the study, neither anti-filgrastim antibodies nor neutralizing antibodies were detected for patients receiving the biosimilar or the reference. In a model-based PD comparison in 82 individuals, PD comparability was demonstrated, and there were no clinically meaningful differences observed in the safety profiles of the biosimilar and the reference.

Pelmeg is now the fourth biosimilar commercialized in Europe by Mundipharma, a network of companies that operates in 120 countries worldwide, which acquired Cinfa Biotech in October 2018; the company is engaged in an ongoing partnership with Korean drug maker Celltrion to commercialize Remsima (biosimilar infliximab), Truxima (biosimilar rituximab), and Herzuma (biosimilar trastuzumab) in Europe.

Mundipharma estimates that its current portfolio of marketed biosimilars have already saved European health systems the equivalent of approximately $377 million, and says that further savings are possible if patients are switched from the reference Neulasta to Pelmeg.

In addition to access to the biosimilar pegfilgrastim, acquisition of Cinfa Biotech provides Mundipharma with additional research and development capacity for future biosimilar products. Mundipharma says that it will continue to develop its biosimilars portfolio and extend its geographic footprint.

Reference

1. Roth K, Wessels H, Hoefler J, Jankowsky R. Comparability of pharmacodynamics and immunogenicity of B12019, a proposed pegfilgrastim biosimilar to Neulasta. Presented at the American Society of Hematology 59th Annual Meeting and Exposition 2017, December 9, 2017; Atlanta, GA. Abstract 1002. https://ash.confex.com/ash/2017/webprogram/Paper100922.html