EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold
Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.
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Two biosimilar versions of Amgen’s blockbuster drug, Neulasta, are up for an opinion from the European Medicines Agency this week on whether they should be approved in the EU. Coherus is the sponsor of one of the products.
Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.
Apotex is hoping to sell its biosimilar version of Amgen’s Neulasta at a 25% discount in Canada after gaining approval there in what seems to be a world first. Might the Canadian OK help unblock the path to approval in the US and the EU?