Mundipharma has announced the launch of Pelmeg (pegfilgrastim), a biosimilar of Neulasta, following its European Commission (EC) approval in November 2018.
The drug is now available in Germany, the Netherlands and Ireland, where it is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Pelmeg is the fourth biosimilar medicine to be commercialised by Mundipharma, expanding its portfolio and commercial footprint across Europe, and was developed by Cinfa Biotech which was acquired by Mundipharma and announced in October 2018.
“We are delighted that Pelmeg is now available in these countries. The launch of the treatment builds on our proven commercial excellence in biosimilars over the past four years. Pelmeg has the potential to play an important role in improving the lives of patients affected by chemotherapy induced neutropenia and febrile neutropenia,” said Philippe Bastide, head of biosimilars, Europe.
“Through our partnership with Celltrion, we estimate Remsima and Truxima have already saved European healthcare systems approximately €330m. If all patients currently being treated with the reference product are offered access to Pelmeg, further significant savings can be realised for the healthcare community.”
The approval of Pelmeg was based on a robust regulatory submission of rigorous analytical, biofunctional, preclinical and clinical studies to demonstrate biosimilarity in terms of its quality, safety and efficacy profile.