Race for a slice of Humira revenues, as Amgen files first biosimilar MAA with EMA
In a global biosimilars market expected to reach a value of $20 billion by the end of 2015 and could hit $55 billion by 2020, according to business intelligence provider GBI Research, the race for applications for approval of such “follow-on biologicals” is heating up.
The latest news is from US biotech major Amgen (Nasdaq: AMGN), which on Friday revealed it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 501, a biosimilar candidate to AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) which loses patent protection next year.
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the European Union, where the regulatory approval path is already well established compared with that in the USA.
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