Amgen prepped to compete in US filgastrim market post Sandoz's Zarxio launch

By Dan Stanton

- Last updated on GMT

Amgen set to compete in a world of increasing players when Sandoz launches its Neupogen biosimilar in September
Amgen set to compete in a world of increasing players when Sandoz launches its Neupogen biosimilar in September

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Neupogen to bring in substantial future sales despite the arrival of Sandoz's biosimilar Zarxio in September, says Amgen.

Last week, an appeals court ruling gave Novartis subsidiary the go-ahead to begin selling its cancer treatment Zarxio (filgastrim) from September. The product is a copycat version of Amgen’s Neupogen and the decision heralds a new era by exposing the US market to biosimilar competition.

But while the decision could hit Amgen sales, the firm remains resolute its proprietary drug would continue to generate substantial sales going forward and, during a conference call to discuss results yesterday, said Neupogen is already subject to competition.

“Although Sandoz's biosimilar against Neupogen will serve as the first true biosimilar entrant into the US market, Teva's Granix has served as somewhat of a proxy, having captured about 17% share of the short-acting filgrastim market after about 18 months in the market,”​ Amgen’s Executive VP of Global Commercial Operations told stakeholders.

Granix was approved in the US in August 2012, but while it has the same active ingredient (G-CSF) as Neupogen and is deemed a biosimilar in Europe, the product was filed by Teva through the proprietary drug pathway.

US Neupogen sales for 2012 stood at just over $1bn (€900m) but two years on annual revenues fell to $840m. For the second quarter 2015, Amgen reported further decline with US Neupogen sales clocking in $191m, down 14% on the same period 2014.

Prepped to compete

However, Hooper said Amgen would continue to fight for market share despite further competition from Sandoz and others.

“We're planning for the arrival of new competition and are prepared to compete,”​ he said. “We will leverage the success that we've had in the US versus branded competition as well as our considerable experience competing against ESA [Erythropoiesis-Stimulating Agents] and NEUPOGEN biosimilars in Europe.”

Amgen’s ESA drug Epogen (epoetin alfa), has several versions available in non-US markets, including ones marketed by Hospira, which earlier this year​ filed its biosimilar for review in the US.

“We expect our products to continue to generate substantial cash flows for years to come, even after competitors enter the market.”

Related topics Markets & Regulations Biosimilars

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