EMA accepts Sandoz Neulasta biosimilar for review

Sandoz says the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), for review.

Sandoz is seeking approval for the same indication as the reference product, which is used to help alleviate some of the side effects of cancer chemotherapy treatment and reduce the risk of infection by boosting white blood cells.

Pegfilgrastim is the fifth of 10 biosimilars that the Novartis generics unit aims to submit to regulators between 2015 and 2017. The FDA accepted the latest biologic for review in November.

On reaching the halfway stage of this target, Richard Francis, division head and chief executive of Sandoz, comments: "Securing five major regulatory file acceptances in five months demonstrates substantial progress on our long-term biosimilars investment strategy. 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 said it is confident in the evidence it has submitted to EMA, which includes data from three pivotal clinical trials- one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients. The company expects this to satisfy the regulator that its version of pegfilgrastim is of high similarity to Amgen’s.

Joel Levy