Celltrion, a South Korean biopharma, said that despite receiving Complete Response Letters from the FDA, it remains optimistic it will get U.S. approval for its two biosimilar drugs, Rituxan and Herceptin, by the end of the year.
In acknowledging the CRLs from the regulatory agency, the company said in a statement posted on its website that, “Celltrion is confident that the issues raised by the FDA will be resolved in a timely manner. We can confirm that the resubmission will be in-place relatively soon. Then, we are expecting approvals in 6 months after resubmission according to regulatory timeline.”
An FDA delay in approving the two candidates could allow other biosimilar competitors to enter the market before Celltrion. Novartis submitted its FDA application for the Rituxan biosimilar two months after Celltrion and is on track for approval sometime in the second quarter of this year. Amgen submitted its application for its Herceptin biosimilar at the same time as Celltrion and is on track for approval in the second quarter of this year as well.
The FDA hit the Celltrion plant where it produces the APIs for the biosimilar candidates for Rituxan and Herceptin with a warning letter earlier this year. Israel-based Teva, which is undergoing a $3 billion corporate cost-cutting effort, has agreed to pay Celltrion up to $160 million in a licensing deal for the two drugs in the U.S. market.
In its warning letter, the FDA cited the facility for having poor practices in the aseptic fill area and ordered the company to do a retrospective assessment of all media fills for the last four years. It also pointed out issues about the plant’s investigation of visible particles in finished drug products that were bound for the U.S., among other issues.
The agency recommended Celltrion consider hiring outside experts to help it get its production in order.
In an analyst call shortly after the warning letter was issued, Teva CEO Kåre Schultz said the FDA warning was for issues the agency had with the finished products portion of the plant, the areas where fill-finish is done, and not the production area where the API is manufactured for its anticipated migraine drug fremanezumab. He added at the time that Teva was in talks with the FDA about the impact the factory issues could have on approval.
In the future, Teva will have tighter control over its biologics manufacturing when work on its $200 million biologics plant in Ulm, Germany. The project is expected to be completed in 2020.