Sandoz’s biosimilar pegfilgrastim accepted for European regulatory review

Sandoz has announced that its new biosimilar version of pegfilgrastim has been accepted for review by the European Medicines Agency.

The regulator will assess the company's marketing authorisation application for the biosimilar version of Amgen's branded product Neulasta, a prescription medicine used in cancer patients to help with some of the side effects of their treatment.

It works to reduce the duration of neutropaenia, a condition characterised by a drop in the white blood cells that fight infection, and which is often accompanied by fever. This is an issue that is associated with a number of common chemotherapy regimens.

Data from three pivotal clinical trials has shown that the biosimilar performs near-identically to the original reference product.

Richard Francis, division Head and chief executive officer of Sandoz, said: "Further advancing our biosimilars pipeline is an important priority for us this year and we'll continue to invest significantly in bringing our pipeline to patients."

Sandoz has now obtained five major regulatory filing acceptances for biosimilar products in the last five months.