Celltrion Healthcare has launched its Avastin biosimilar Vegzelma (ingredient: bevacizumab) to treat metastatic colorectal cancer and breast cancer in the U.S., starting the direct sales of its treatments in the country.

Following its approval from the U.S. Food and Drug Administration (FDA) in September of last year, Celltrion Healthcare has been striving to enhance the competitiveness of its U.S. subsidiary, with the aim of achieving a successful launch and sales of Vegzelma.

With the inclusion of experienced professionals from leading global biopharmaceutical companies, Celltrion Healthcare has expanded its U.S. subsidiary organization to over 50 staff members. Notably, Thomas Nusbickel, who has amassed over 30 years of experience in the biopharmaceutical industry, serves as the Chief Commercial Officer of the U.S. subsidiary.

In addition to expanding its staff, Celltrion Healthcare is broadening its communication channels with key stakeholders, such as Group Purchasing Organizations (GPOs), Medicaid, and private insurers. The company aims to establish strong relationships with these groups to ensure the successful commercialization and uptake of its treatment options in the U.S. market.

Celltrion said Vegzelma has already been added to the Medicare reimbursement list, and it will commence its initial shipment to major wholesalers this week.

Celltrion Healthcare is actively negotiating with multiple private insurers with the goal of achieving coverage by 60 percent of them by the end of this year.

Celltrion Healthcare anticipates that the successful prescription outcomes of its existing products in the U.S. will pave the way for Vegzelma to expand its stable prescription base.

According to Symphony Health, a U.S. pharmaceutical market research firm, Remsima (active ingredient: infliximab) maintained its position as the top biosimilar product with a market share of 31.4 percent in the U.S. as of March.

Truxima (active ingredient: rituximab) has steadily expanded its prescription base by surpassing a 30 percent market share four years after its launch in 2019.

"Vegzelma is the first product we are directly selling in the U.S., and it is of great significance for the company," Celltrion Healthcare CEO Kim Hyung-ki said. "Therefore, we plan to actively pursue market access and marketing activities to establish our presence in the U.S. market successfully."

Starting with Vegzelma, we will sequentially release products in the U.S., such as Yuflyma, scheduled to be launched in the latter half of this year, and Remsima SC, a new drug currently in the process of regulatory approval, aiming to take another step forward as a global leading bio company, Kim added.