Teva Pushes CGRP Timeline Back To End Of 2018
Management said the migraine drug fremanezumab could launch in the US by the end of the year following discussions with the US FDA. The June timeline has been delayed by a Celltrion manufacturing issue.
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The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.
Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.
One of Teva's few bright spots is its leading position in the big new commercial opportunity for migraine, but its CGRP drug fremanezumab could now be delayed by an issue at third-party manufacturer Celltrion.