Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim

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.