CHMP positive for biosimilar pegfilgrastim to treat same indications as its reference medicine. Sandoz

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim,(Zioxtenzo), a long-acting version of supportive oncology care medicine filgrastim. While pegfilgrastim is a proven effective and safe treatment for febrile neutropenia-related infections, many cancer patients throughout Europe are not treated with this medicine. This biosimilar medicine is expected to match the reference medicine in terms of safety, efficacy and quality.

Pegfilgrastim is a long-acting form of filgrastim, a biosimilar medicine that stimulates the production of white blood cells and stem cells. Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine, for the prevention of chemotherapy-induced infection, known as febrile neutropenia, which includes fever brought on by low neutrophils (a specific type of white blood cells). The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality. Febrile neutropenia is a serious and possibly life-threatening condition that can develop in people with cancer who receive who receive chemotherapy. Despite treatment advances, febrile neutropenia may pose risks to a person's chemotherapy treatment plan, with consequences such as dose reductions, discontinuation of treatment or changing to a less effective regimen.

Comment; The EU patents for pegfilgrastim expired in August 2017 and the US patents expired in October 2015.