Celltrion's Zymfentra makes US debut

Korean biopharmaceuticals firm Celltrion announced Monday that its new autoimmune disease treatment Zymfentra has been launched in the US market.

Zymfentra is a subcutaneous injection formulation of Celltrion's infliximab Remsima. In October last year, the US Food and Drug Administration approved Zymfentra (infliximab-dyyb) for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

"Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn's disease," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the US to have greater flexibility in managing their disease."

Celltrion said the wholesale acquisition cost of two injections of Zymfentra, which a patient needs in four weeks, has been set at $6,181. “The company has been able to set an optimal price for the drug considering the prices of its competing products,” Celltrion said.

Celltrion will focus on increasing Zymfentra’s share in the US inflammatory bowel disease market, which is about 12.8 trillion won ($9.6 billion) in size, the company said, citing data from health care researcher IQVIA.

Celltrion expressed hopes that Zymfentra would drive the company’s long-term revenue growth. The company said it would aim to raise over 1 trillion won in annual sales with Zymfentra by 2025 and afterward.

The company added that Zymfentra will be under patent protection until 2037 for its dosage form and until 2040 for route of administration.

Celltrion expects Zymfentra will increase its share in the US market due to the treatment’s efficacy and accessibility.

"The burden of Crohn's disease and ulcerative colitis on patients' daily lives is substantial," said Michael Osso, president and CEO of the Crohn's & Colitis Foundation. "This is a meaningful advancement for eligible adult patients with Crohn's disease and ulcerative colitis, who now have more options and can receive treatment of Zymfentra at home, through subcutaneous delivery, allowing more flexibility and choice."