Mundipharma announced today that it has launched Pelmeg, a biosimilar pegfilgrastim referencing Neulasta, 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
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
AAM Report: Despite Massive Savings, Patient OOP Costs on Biosimilars, Generics Remain High, Part 2
September 24th 2024Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1
September 18th 2024Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the Association for Accessible Medicines (AAM).