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Sandoz files for approval of Neulasta biosimilar in Europe

Amgen facing increasing competition in global biosimilar market


Novartis' Sandoz unit has filed for approval of its fifth biosimilar in Europe, this time taking aim at the market for Amgen's Neulasta.

The European Medicines Agency (EMA) has now started its review of the Neulasta (pegfilgrastim) biosimilar - a long-acting granulocyte colony-stimulating factor (GCSF) that is used to prevent low white cell counts and resulting infections in patients undergoing cancer chemotherapy setting up a possible approval before year-end.

Neulasta is Amgen's second-biggest product, bringing in $4.72bn in sales last year, but it is facing the threat of biosimilar competition in many markets around the world.

Sandoz has also filed for approval of its biosimilar in the US, which accounts for the bulk of sales. Europe and other world markets accounted for just $824m of Neulasta turnover last year.

The generic drug specialist - which also sells a biosimilar version of Amgen's short-acting GCSF product Neupogen (filgrastim) - said the Neulasta filing means it is now halfway to its objective of submitting 10 biosimilars from its late-stage pipeline.

The company is seeking the same indication for its version as Neulasta and has backed up its marketing application with three pivotal clinical trials which "demonstrate that the proposed biosimilar is highly similar to the reference product".

Meanwhile, Amgen has been trying to defend Neulasta from competition with the launch of the Neulasta Onpro kit, which includes a single dose of the drug and a disposable injector system worn like a patch on the arm. It avoids the need for a return visit to the doctor the day after chemotherapy is administered.

As many patients elect to have chemotherapy treatment on a Friday, which gives them the weekend to recover, they need to attend a clinic on Saturday for their last Neulasta injection. The Onpro kit avoids that and also prevents patients taking a Neulasta dose early - or skipping it altogether - which can dramatically reduce efficacy.

Launched last year, the new formulation accounted for almost a quarter of all Neulasta prescriptions in the US in the fourth quarter, according to Amgen, which has indicated it does not expect a biosimilar launch in the US "until the end of the year at the earliest".

The patents on Neulasta expired in the US in October 2015, but remain in force in Europe until August 2017, according to data from the Generics and Biosimilars Initiative (GaBi).

Article by
Phil Taylor

11th February 2016

From: Regulatory



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