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Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim.

Sandoz, a Novartis, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim. Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe. 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. 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 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. The European Commission takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions based on the EC's recommendation.

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Publication:The Fly
Date:Sep 21, 2018
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