Displaying confidence in plant upgrades, Celltrion hustles application for Herceptin biosimilar back to the FDA

Celltrion plant
Celltrion, which received a complete response letter for its Herceptin biosimilar tied to a warning letter received this year, has already resubmitted its application for the candidate. (Celltrion)

South Korea’s Celltrion has resubmitted the application for its biosimilar of Roche’s blockbuster cancer drug Herceptin, just weeks after doing the same for its biosimilar candidate of Rituxan. Both had been sidelined by the FDA because of problems at the Celltrion plant that were laid out in a January warning letter.

Celltrion said today that the FDA “has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of the aBLAs.” It pointed out that FDA regulations allow for the approval procedure to be completed within six months of the resubmission, so Celltrion expects the approval of the drug candidates "this calendar year.”

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

Last fall, Celltrion sold U.S. and Canadian marketing rights to its Herceptin and Rituxan biosimilars to Israel’s Teva Pharmaceutical Industries for $160 million. The companies will share profits through the arrangement. As part of the agreement, Celltrion is responsible for getting the candidates approved and Teva is responsible for all commercial activities in the U.S. and Canada. The companies will share profits.

If Celltrion is able to get approvals this year, it will be a quick turnaround, since it often can take more than a year to resolve warning letter issues with the FDA. So far, the FDA regulatory path has been littered with complete response letters and delays for copies of Herceptin. Pfizer, Amgen, and Mylan and partner Biocon have all had their initial applications delayed by U.S. regulators. Mylan and Biocon finally won approval of theirs in December.

RELATED: Celltrion biosim, eyeing Herceptin's megasales, measures up to the Roche med in phase 3

To bolster its case for approval, Celltrion last week reported that in a head-to-head test against Herceptin, its CT-P6 turned in similar safety and efficacy to the Roche med as a presurgery treatment for HER2-positive early breast cancer.