The approval of Pelmegis follows the recommendation of the Medicinal Products for Human Use (CHMP), which was based on regulatory submission of significant biosimilarity data from analytical, biofunctional and clinical study comparisons for Pelmeg.
The biosimilar demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta, which was produced by Amgen.
Mundipharma International biosimilars head Philippe Bastide said: “We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia.
“The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”
Pelmeg is said to be the fourth biosimilar medicine that will be commercialized by the Mundipharma network. Pelmeg was developed by Cinfa Biotech, which was acquired by Mundipharma network.
An analytical, biofunctional, preclinical and clinical comparability program has showed a high degree of similarity between Pelmeg and Neulasta.
According to the company, Pelmeg’s biosimilarity was assessed in healthy volunteers who have no comorbidities, require no co-medication and are immunocompetent.
The data has proved biosimilarity of Pelmeg to Neulasta in sensitive clinical study settings and showed pharmacokinetic comparability to Neulasta at the clinical dose of 6mg.
It also did not demonstrated any clinically meaningful differences in the safety and immunogenicity profile compared to Neulasta.
Pelmeg is a biosimilar of pegfilgrastim, which is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, enabling to reduce the incidence of febrile neutropenia.
Pelmeg is administered as a subcutaneous injection once per chemotherapy cycle, and should be at least 24 hours after cytotoxic chemotherapy.
The Mundipharma network of independent associated companies hold distribution and marketing rights from Celltrion Healthcare for three prior biosimilars, including Remsima, Truxima and Herzuma.
In 1956, the doctors founded the Mundipharma global network of privately-owned independent associated companies. It is currently having operation in more than 120 countries across the globe.