April 25, 2024

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[THE INVESTOR] The US Food and Drug Administration’s decision to turn down Celltrion’s applications for two biosimilar candidates will disrupt the timing of approvals but their launch schedule is likely to remain intact, the Korean firm said on April 6.

“The US launch of Truxima and Herzuma will still be in line with our initial plan as they can hit the market only after the original drugs’ key patents lapse,” a Celltrion official told The Investor. 

In February and March, the FDA issued two separate complete response letters to Celltrion, declining to approve Truxima, its version of Roche’s Rituxan, and Herzuma, a biosimilar of Roche’s Herceptin, disappointing investors who had anticipated clearance of the final regulatory hurdle in the first half of this year. The Korean company said the FDA sought additional data on manufacturing process and drug production facilities.

Celltrion expects to get approvals within this year and the US agency’s action will not have a major impact on sales of the biosilimars as the patents on Herceptin will expire in the US in June 2019 while Rituxan loses its main patent protection in July 2018.

“Even if Truxima gains approval before June, we have to wait until another antibody-related cell expression patent called Cabilly’s patent expires in December,” he said.

A longer delay could give its rival Sandoz a chance to be the first to have its Rituxan biosimilar to gain US clearance as it was put under FDA review only three months later than Celltrion.

Ku Wan-sung, an analyst at NH Investment & Securities, said Celltrion is expected to resolve the biosimilar site issues by the third quarter this year. “Mylan and Biocon received a complete response letter in October 2017 related to production issues with Ogivri, their biosimilar version of Herceptin. However, the company took prompt actions to resolve such issues and FDA approved the drug in December 2017, meaning that the approval process was delayed by only three months,” he said.

Ku added that he believes Herzuma and Truxima will be approved in the fourth quarter of 2018.

By Park Han-na (hnpark@heraldcorp.com)