Novartis and Sandoz's new biosimilar cancer drug accepted for EU review

Pharmaceutical Company Product News

Novartis and Sandoz have announced that their newest biosimilar cancer therapy pegfilgrastim has been accepted for European regulatory review.

The European Medicines Agency has accepted the companies' marketing authorisation application for biosimilar pegfilgrastim, an affordable new equivalent of Amgen's branded cancer drug Neulasta.

“Novartis and Sandoz's new biosimilar pegfilgrastim has been accepted by the European Medicines Agency for regulatory review.“

A comprehensive data package has demonstrated that biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality in the treatment of breast cancer, but at a much lower cost.

Pegfilgrastim is a long-acting version of another oncology medicine, filgrastim, for which Sandoz is the leading European supplier.

Dr Mark Levick, global head of development for biopharmaceuticals at Sandoz, said: "Our goal is to improve patient access to important biologic medicines and the European Medicines Agency file acceptance of our biosimilar pegfilgrastim is a move towards doing just that."

Sandoz is emerging as a global leader in the field of biosimilars, with products of this kind marketed worldwide, as well as three proposed biosimilars under review in Europe: pegfilgrastim, adalimumab and infliximab.

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