Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar
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Pegfilgrastim-jmdb/MYL-1401H (FULPHILA™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neutropenia, in the USA and to reduce the duration of neutropenia and the incidence of febrile neutropenia in the EU. Pegfilgrastim-jmdb has similar physicochemical characteristics and functional properties to those of US- and EU-sourced reference pegfilgrastim, and the pharmacodynamic and pharmacokinetic similarity of the agents has also been demonstrated in healthy volunteers. Pegfilgrastim-jmdb demonstrated clinical efficacy equivalent to that of EU-sourced reference pegfilgrastim in patients with newly diagnosed Stage II/III breast cancer receiving neoadjuvant or adjuvant chemotherapy and was generally well tolerated in this patient population. The overall safety profile and immunogenic potential of the two agents was similar. The role of reference pegfilgrastim in the management of chemotherapy-induced neutropenia is well established and pegfilgrastim-jmdb provides an effective biosimilar alternative for patients requiring pegfilgrastim therapy.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of pegfilgrastim-jmdb/MYL-1401H was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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