Sandoz is seeking approval for use of its biosimilar to Amgen’s Neulasta, EMA to take a look at it

Novartis division Sandoz has gotten acceptance for its biosimilar to Amgen’s Neulasta by the European Medicines Agency (EMA) for regulatory review, Novartis said on Friday.

Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.

Mark Levick, Global Head of Development, Biopharmaceuticals said that the goal is to improve patient access to important biologic medicines. “The EMA file acceptance of our biosimilar pegfilgrastim is a move towards doing just that,” he said.

He added that, if approved, the company will look forward to supporting cancer patients, healthcare professionals and payors with its biosimilar pegfilgrastim.

As the global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. Sandoz currently has three proposed biosimilars under review by the EMA: pegfilgrastim, adalimumab and infliximab.

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