Coherus Files On-Body Pegfilgrastim, Says ‘People Talk’ On Potential Rivals
Amgen’s Neulasta Onpro Device Continues To Hold More Than 40% Of Market
Having previously underlined that it would not tell the market the exact moment it filed its proposed biosimilar pegfilgrastim on-body injector device, Coherus BioSciences has now confirmed a filing was completed late last year.
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Coherus BioSciences has swiftly returned a filing for its on-body pegfilgrastim biosimilar candidate to the US Food and Drug Administration, while hitting a milestone for its Cimerli biosimilar to Lucentis (ranibizumab).
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”
Fresenius Kabi has delivered on long held ambitions to join the biosimilars party in the US, offering another pegfilgrastim subcutaneous injectable in a crowded market of biosimilar sponsors.