FDA issues complete response letters for Celltrion's proposed biosimilars for Roche's Rituxan, Herceptin

(Ref: The Korea Herald)

Celltrion said Thursday that the FDA has issued a complete response letter for its biologic license applications for Truxima and Herzuma, which reference Roche's Rituxan (rituximab) and Herceptin (trastuzumab), respectively. The biosimilar products were expected to gain marketing approval before June, although Celltrion indicated "we are committed to working with the regulatory agency to fully resolve all outstanding issues with an aim to receive approval this year."

The FDA action follows a warning letter issued to Celltrion in January related to a 2017 inspection conducted at the company's drug manufacturing facility in Incheon, South Korea. The letter cited both production facility and manufacturing process issues.

Truxima and Herzuma were granted EU approval in 2017 and 2018, respectively. Last month, Celltrion partner Nippon Kayaku announced that Herzuma, also known as CT-P6, obtained approval in Japan.

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Meanwhile, Celltrion filed lawsuits earlier this year in California district court against Roche's Genentech unit, challenging the validity of 38 patents relating to Herceptin and 37 patents relating to Rituxan.

In January, Celltrion chairman Seo Jung-jin said the company would begin preparations to build its first overseas production plant this year and confirm a site for the biologics facility before June. The executive noted more recently that the company's Celltrion Healthcare unit expects sales to climb by more than 70 percent this year on strong biosimilar sales. "Conservatively speaking, I would say Celltrion Healthcare sales will reach between 1.6 trillion won ($1.5 billion) and 2 trillion won ($1.9 billion) in sales," he remarked at that time.