FDA approves second Neupogen biosimilar

Already facing competition from Sandoz, Amgen’s Neupogen white blood cell stimulator faces another cut-price near-copy after the FDA approved Pfizer’s biosimilar, Nivestym.

Nivestym has been approved in all the same indication’s as Neupogen (filgrastim), after clinical trials showed that it was highly similar to the originator.

Sandoz, Novartis' generics and bisimilars division, became the first company to get a biosimilar approved by the FDA in 2015 with its biosimilar of Neupogen, called Zarzio.

Neupogen went off-patent in the US in 2013 and have already been affected by the competition – in Q1 they were down 30% compared with the same period last year.

The total worldwide sales of $103 million in Q1 are a fraction of the sales that Neupogen once generated.

Berk Gurdogan, US institutions president at Pfizer Essential Health, said: “The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy.”

“We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

Granulocyte colony stimulating factors such as Neupogen are given to decrease the chance of infection in patients with certain cancers who are receiving immunosuppressive chemotherapy.

Amgen has produced a long-lasting version known Neulasta (pegfilgrastim), which generates sales of just over a billion dollars per quarter.

But it too is facing competition from a biosimilar – Mylan’s Fulphila was approved by the FDA early in June.

Biosimilars are near-copies of complex biological drugs that must be manufactured using living cells, and have their own specialist approval pathway in the US and Europe.

Development of biosimilars is still expensive, but slightly less that developing a completely new biologic drug.

As such they are usually sold at a substantial discount to the originator drug, but not at the rock-bottom prices associated with conventional generic drugs.