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Fresenius Kabi Concedes On FDA Pegfilgrastim Chances

German Firm Also Rules Out Humira Interchangeability Designation

Executive Summary

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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Accord’s Teriparatide And Fresenius Kabi’s Pegfilgrastim Satisfy CHMP

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.

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