Celltrion Chairman Seo Jung-jin said Wednesday that U.S. sales for Truxima, a Rituxan biosimilar which received approval from the U.S. Food and Drug Administration last year, is imminent.
|Celltrion Chairman Seo Jung-jin explains the company’s current position in the U.S. market and its global goals, during the Korea Investment Festival 2019 held at the 63 Building in Yeouido, Seoul, Wednesday.|
“The company plans to launch Truxima in the United States soon and will also launch Herzuma shortly,” Seo said during his speech at the Korea Investment Festival 2019 held at the 63 Building in Yeouido, Seoul. “Celltrion has also cleared patent issues with Roche, which holds the original drug Rituxan.”
Truxima is the first mover in a treatment where only an original drug exists, he added.
Seo stressed that sales for Truxima and Herzuma would start generating sales in earnest from the beginning of next year.
Regarding the sales approval for Remsima SC, Seo said, “In the U.S. and Japan, Remsima SC is considered a new drug and not a biobetter. The company expects to receive regulatory approval from Europe in November and those of other countries, excluding the U.S. and Japan, by August of next year.”
In the U.S., the company plans to submit its investigational new drug in March, he added.
Seo also noted that through close talks with the FDA the company has received a considerable amount of exemption and plans to launch the drug by 2020.
The chairman also expressed his confidence in the transition to the direct sales system. According to Seo, Celltrion will have a direct sales system in all regions except the U.S. and Canada by the end of this year, while completing its conversion in Canada and U.S. by 2020 and 2021, respectively.
“In working with partners, we have identified most of the key selling points, including major tenderers and core doctors, in Europe,” Seo said. “We expect we will be able to reduce the 40 percent commission to 15 percent, which, in turn, will allow us to gain additional profit by selling Celltrion products as well as products from other companies.”