Fresenius Files Tocilizumab Biosimilar With EMA
Follows Earlier Announcement Of Kabi’s US FDA Filing For Actemra/RoActemra Rival
Fresenius Kabi has followed a US filing for its MSB11456 proposed tocilizumab biosimilar with a parallel marketing authorization application in the EU for its rival to RoActemra.
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Newly instated Fresenius group CEO Michael Sen took charge of his first earnings call following his appointment on 1 October, pushing the message of Kabi managing its own destiny amid a series of macroeconomic challenges.
The European Medicines Agency has accepted Biogen’s marketing authorization submission for its BIIB800, developed by Chinese firm Bio-Thera.
Fresenius Kabi has set out launch plans after receiving its first US biosimilar approval, for its Stimufend pegfilgrastim rival to Neulasta.