Fresenius Kabi Concedes On FDA Pegfilgrastim Chances
German Firm Also Rules Out Humira Interchangeability Designation
Fresenius Kabi is continuing to suffer from the longstanding effects of the US FDA backlog for onsite inspection reviews amid the coronavirus pandemic. Management discussed Kabi’s latest prospects on its proposed pegfilgrastim biosimilar, as well as adalimumab and tocilizumab.
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Fresenius Kabi has set out launch plans after receiving its first US biosimilar approval, for its Stimufend pegfilgrastim rival to Neulasta.
Fresenius Kabi’s Q1 call spanned its recent launch of a generic version of Takeda’s Velcade subcutaneous injectable to the company’s continued ambitions in biosimilars, with the German firm’s acquisition of a controlling stake in mAbxience scheduled to close by the middle of the year.
Positive CHMP opinions recommending European marketing authorizations have been granted for Accord’s teriparatide and Fresenius Kabi’s pegfilgrastim biosimilars, while the sponsor for an ophthalmic version of bevacizumab has asked the EMA to take a second look at the rejection of its application. Three Accord generics were also endorsed by the CHMP at its January meeting.