- Positive opinion is based on comprehensive data confirming that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality
- Sandoz seeks approval in the same indication as the reference medicine, for prevention of febrile neutropenia, one of the most serious side effects of cancer chemotherapy
- Sandoz is the global leader in biosimilars and continues to improve patient access and support sustainable healthcare with seven approved biosimilars
Holzkirchen, September 21, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today 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, *** a long-acting version of supportive oncology care medicine filgrastim.
"The burden of cancer and its treatment - specifically chemotherapy - is something Sandoz has worked tirelessly to address for more than three decades," said Mark Levick MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz.
"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. Our biosimilar medicine is expected to match the reference medicine in terms of safety, efficacy and quality. If approved, we will do our best to provide this critically-important option to all patients who stand to benefit from it."
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 (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 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 (EC) 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 (EEA), will take corresponding decisions based on the EC’s recommendation.
Pegfilgrastim is a long-acting version of filgrastim and belongs to a group of proteins called cytokines. It is similar to a natural protein (granulocyte-colony stimulating factor) produced by a person’s own body, and may be used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection. Preventing febrile neutropenia is essential because the condition itself can delay and interrupt cancer treatment, and cause serious infections, such as sepsis, and ultimately death.