The Mundipharma network of independent associated companies says European regulators have approved use of Pelmeg, a biosimilar of Amgen’s white blood cell booster Neulasta.
Pelmeg has been cleared to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy.
The decision rides on the back of an endorsement by the Committee for Medicinal Products for Human Use (CHMP), which concluded that Pelmeg (pegfilgrastim) demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product.
“We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia,” said Philippe Bastide, head of Biosimilars at at Mundipharma International.
“The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option”.
Pelmeg was developed by Cinfa Biotech, which was acquired by the Mundipharma network earlier this year.