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South Korea-based pharmaceutical company Celltrion Inc. received approval for its new drug, Remsima SC, from the US Food and Drug Administration (FDA). The drug offers a promising treatment option for individuals suffering from autoimmune diseases.
It contains the active ingredient infliximab, also known as Zymfentra in the American market, the Yonhap News Agency noted.
New Drug Approval and Patents
Remsima SC marks Celltrion's first FDA-approved drug. The company has filed a patent application to safeguard its proprietary rights, focusing on the drug's formulation and mode of administration, to maintain exclusivity until 2040.
Zymfentra, the subcutaneous injection (SC) variant of the antibody biosimilar Remsima, expands Celltrion's treatment options for autoimmune diseases. With approvals in over 50 countries, including Europe and Canada, Zymfentra's availability in the US market solidifies Celltrion's global presence.
According to KED Global, Celltrion credits the FDA's guidance and collaboration from the early negotiation stages for the smooth licensing process. Following the FDA's suggestions, Celltrion conducted two global Phase 3 clinical trials and submitted the approval application in December of last year.
"The approval of Zymfentra provides an innovative and effective treatment option that offers patients with inflammatory bowel disease an alternative administration option providing control of how and where they receive their treatment," said Thomas Nusbickel, chief commercial officer at Celltrion USA.
Projected Success, Revenue Forecast
With the expected launch of Zymfentra, Celltrion anticipates an annual turnover of over 600 billion won ($443.7 million) and a three-year revenue forecast of 3 trillion won. This exponential growth is attributed to collaborative synergies with Celltrion's existing US market entries, Remsima and Yuflyma, further consolidating their foothold in the US market.
To enhance cost efficiency, Celltrion plans to discontinue intermediary purchasing and selling activities through Celltrion Healthcare. The company aims to strengthen its direct sales network, allowing seamless access to Remsima SC in the US market.
Photo: Celltrion Newsroom
