Celltrion and its marketing partner Teva Pharmaceutical Industries said Thursday that the US FDA’s Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend the approval of CT-P10, indicating the drug is highly likely to win the FDA’s final approval.
The decision came as the independent committee found no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for three proposed indications, including Non-Hodgkin’s lymphoma.
|Celltrion's headquarters in Songdo, Incheon (Park Hyun-koo/The Korea Herald)|
CT-P10 is Celltrion’s biosimilar referencing Rituxan (rituximab), also known by the name Truxima. It has already been approved for sale by Europe’s drug regulator as of February 2017.
With strong backing, the drug will now be sent to the FDA regulator for final consideration. If approved, Celltrion’s biosimilar would be the first Rituxan copy to be commercialized in the US, Celltrion CEO Kee Woo-sung said in a statement.
Teva, which holds the exclusive right to market Truxima in the US and Canada under a partnership with Celltrion, welcomed the FDA committee’s decision and pledged to successfully commercialize the drug in the US.
“If approved, Teva is well-positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience,” said Brendan O’Grady, executive vice president and head of North America Commercial at Teva.
Rivals, such as Novartis, are also working to secure swift approval for their Rituxan biosimilars. However, prospects of approval for Novartis’ Rituxan biosimilar were delayed when the US FDA initially rejected the drug in May with a complete response letter, citing irregularities.
Celltrion had suffered a similar setback earlier this year, when the FDA rejected Truxima over manufacturing issues at its plant in Songdo, Incheon. Celltrion refiled the drug for approval in May, and said it expected to win final FDA approval by the year’s end.
By Sohn Ji-young (firstname.lastname@example.org)