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FDA accepts Sandoz filing for biosimilar Neulasta

Theversion of Amgen's blockbuster will have a 10-month review period

Novartis Sandoz

Sandoz has filed for approval in the US for a biosimilar version of Amgen's blockbuster white blood cell stimulator Neulasta.

The FDA has just accepted the marketing application, triggering a 10-month review period under the agency's 351(k) regulatory pathway for biosimilars.

Neulasta (pegfilgrastim) is a long-acting granulocyte colony stimulating factor (G-CSF) that is used to bolster white cells in patients undergoing chemotherapy for cancer, and remains one of Amgen's top-selling drugs with sales of $4.6bn last year, $3.6bn of which were made in the US.

Sandoz - a subsidiary of Novartis - is seeking approval for the same indication as the reference product and says the filing is its third for a biosimilar in the US market.

The company has already claimed an FDA approval for Zarxio (filgrastim-sndz) - a competitor to Amgen's shorter-acting Neupogen (filgrastim) brand of G-CSF which achieved sales of $1.2bn last year, with almost three quarters of that total coming from the US.

Meanwhile, Sandoz has also submitted a dossier to the FDA seeking approval for a biosimilar of Amgen's Enbrel (etanercept), the company's biggest-selling drug with sales of $4.7bn in 2014, $4.4bn from the US market.

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), which says Canada's Apotex has also filed for FDA approval of a biosimilar version of the drug.

Sandoz has conducted three pivotal clinical trials on its biosimilar - one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients (PROTECT 1 & 2) - and says these "demonstrate that the proposed biosimilar is highly similar to the reference product".

There is ample evidence that after a slow start the US is prepared to embrace biosimilars, with a string of guidance documents emerging from the FDA in recent months to help drug developers file successful marketing applications.

A few weeks ago for example, the regulator acknowledged for the first time that it is possible for a biosimilar to be interchangeable - and therefore substitutable - with a reference product.

Article by
Phil Taylor

19th November 2015

From: Sales, Regulatory



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