Amgen reported its Q4 results yesterday, and year-on-year worldwide sales of Neupogen (filgastrim) dropped 4% to $263m (€250m) and full-year sales dropped 9% to $1bn “driven by the impact of competition in the US and unfavourable changes in foreign exchange rates,” the firm said in a statement.
In the US, the drug competes against Teva’s Granix (tbo-filgastrim) – approved as a biologic by the FDA in 2014 – and Sandoz’s biosimilar Zarxio, launched in September.
According to the financials, US Neupogen revenue fell 11% in 2015.
Despite this, Amgen still still holds the lion’s share in the US filgastrim market, EVP of Global Commercial Operations Anthony Hooper said during a conference call.
“We've had competition on the market for over a year now plus a biosimilar competitor for close to six months. And we still hold 76% of the market share,” he told investors. “We will compete account by account using our many years of experience competing against biosimilars in Europe and branded competitors globally, but do expect some share loss.”
Sandoz challenge
Novartis also presented its Q4 financials this week, and while global biopharmaceutical sales at its subsidiary Sandoz grew 41% y-o-y to $218m, the firm did not offer a product-by-product revenue breakdown.
Sandoz spokesman Sreejit Mohan told us the firm was pleased with Zarxio’s performance in the US to date, adding that its market share is in line with expectations.
“This is a physician-driven market, so we fully expected more gradual uptake,” he said. “What is important is that Zarxio offers healthcare providers a genuinely new option and we continue our sales, marketing and education efforts.”
The quarter also saw Sandoz challenge Amgen’s TNF-alpha inhibitor Enbrel (etanercept), and Amgen’s Neulasta (pegfilgrastim), both of which were accepted for review by the US Food and Drug Administration (FDA).
Approval of these products could prove lucrative for Sandoz, as for the full year 2015 US Enbrel sales stood at $5.1bn, while Neulasta sales were $3.9bn.