All of Amgen’s products saw worldwide growth in 2014 except for Neupogen (filgrastim) which declined 17% year-on-year, attributed in part to the impact of competition in the US from Teva’s tbo-filgrastim which was approved in an original biologics license application (BLA) by the US FDA in 2012, and not as a biosimilar as is the case in Europe.
With the recent recommendation of Sandoz’ Neupogen copy Zarxio opening the door to actual biosimilars in the US, Amgen is likely to see further erosion of its $1.4bn 2014 revenues in the coming years.
CEO Bob Bradway said the firm had taken into account the threat of competition in guidance for the upcoming year during a conference call yesterday, but despite a number of other blockbusters at threat from biosimilar erosion – Hospira, for example, has just filed its version of Epogen (epoetin alfa) in the US – Amgen is positive about its future revenue streams.
This is due to the development of nine biosimilar programmes of its own, which the company says has placed it in a beneficial position to support both its innovative molecule R&D and carry out discussions with regulators.
“Through time what we have found is that we continue to learn about our own innovative process development efforts by virtue of the work that we’re doing in our biosimilar programme,” Tony Hooper, Head of Global Commercial Operations, said on the call.
“I think our dialogue with the regulators around the world is enhanced by the fact that we’re recognized to be both an innovator and a company that’s seeking to advance biosimilar molecules, so we’ll continue to work both sides of this.”
Amgen has a timeline of 2017 for its first biosimilar launch, and Phase III data for its version of AbbVie’s Humira (adalimumab) is expected this quarter.
For the full year, Bradway described the firm's financials as 'outstanding' with sales up 7% to $20.1bn on 2013, and an adjusted net income growth of 15% to $6.7bn.