Out of the FDA doghouse, Celltrion again seeks Rituxan biosimilar nod

Celltrion, trying to get back on track with two biosimilars it shares with Teva, is returning to the FDA with its versions of the blockbuster cancer treatments.

The South Korean company today said it has resubmitted its application to the FDA for its version of Rituxan. Next month, it will resubmit its Herceptin biosimilar. Both were waved into the pits by the FDA last year because of manufacturing issues.

Because FDA rules call for resubmissions to be acted on within six months, Celltrion said it expects both to be approved for the U.S. market by the end of the year.  It said the FDA has given it a schedule for reinspection of the troubled plant.

The company last year received complete response letters for the biosimilars tied to plant failings that led to an FDA warning letter. But Celltrion said today it "has made progress addressing the concerns raised by the FDA in the Warning Letter and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency."

It is good news for Teva on two fronts. Not only does Teva have a commercialization agreement with Celltrion for the biosimilars in the U.S. and Canada, but the plant’s progress also should mean Teva can again seek approval for its migraine treatment fremanezumab. The API for the highly anticipated drug is made at the same Celltrion plant. The warning letter was confined to the finished product portion of the massive site, but Teva’s yet-to-be-approved headache med was caught in the crossfire and its PDUFA date delayed.   

Earlier this month, Teva CEO Kåre Schultz told analysts that a reinspection of the Celltrion plant appeared imminent and that the drugmaker should be able to secure FDA approval and launch fremanezumab by the end of the year.

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