Celltrion successfully launched Zymfentra (Ramsima SC in the U.S.), the world's only subcutaneous (SC) formulation of infliximab, across the U.S. on March 15th (local time).
Zymfentra was Celltrion's first product to receive New Drug Application approval from the U.S. Food and Drug Administration (FDA) in October of last year. It is approved for the treatment of adult patients with moderate to severe active Ulcerative Colitis and Crohn's Disease, with a recommended dose of 120 mg once every two weeks.
Zymfentra has a Wholesale Acquisition Cost (WAC) of $6,181.08 (based on a four-week supply of two doses).
Zymfentra's currently pending patent applications for the SC formulation and administration will provide patent protection until 2040, ensuring stable mid- to long-term profitability in the U.S., the world's largest pharmaceutical market.
According to pharmaceutical market research firm IQVIA, the U.S. market for TNF-α inhibitors, including infliximab, was valued at approximately $62.57 billion in 2022. Of this, the IBD market, where Zymfentra is focused, is valued at $12.8 billion. Celltrion plans to achieve a prescription penetration rate of more than 10% in the targeted patient population by 2025, the second year of its launch, making Zymfentra a global blockbuster product with annual sales of more than KRW 1 trillion.
Zymfentra will be marketed directly by Celltrion through its U.S. subsidiary, and the company is aggressively promoting the product to penetrate the market.
"Infliximab is a well-established treatment for IBD patients with proven efficacy and safety across Europe and globally," said Thomas Nusbickel, Chief Commercial Officer at Celltrion U.S. "The introduction of Zymfentra to the U.S. market offers patients more flexibility in managing their disease with a treatment option that is not only effective but also convenient."
Indeed, the U.S. medical community is excited about the launch of Zymfentra. The ability to self-administer Zymfentra at home has been met with great interest from local healthcare providers and patients alike.
"Patients with IBD prefer treatments that are safe, effective, and easy to administer," said Dr. Jean-Frederic Colombel, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York. "The availability of Zymfentra in the U.S. will give patients more flexibility and convenience in managing their disease in their daily lives."
