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.
Accord’s Sondelbay (teriparatide) and Fresenius Kabi’s Stimufend (pegfilgrastim) biosimilars should be issued pan-European marketing authorizations, the committee for medicinal products for human use within the European Medicines Agency has recommended.
At the same time, the sponsor behind an ophthalmic version of biosimilar bevacizumab has asked the CHMP to take a second look at its application following a rejection, while the CHMP has also endorsed two versions of Accord’s
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Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.
