Celltrion eyes expansion in light of extended Zymfentra access

Celltrion USA recently announced that Zymfentra (infliximab), a subcutaneous treatment for Crohn's disease and ulcerative colitis, has earned expanded access in the US through continued partnerships with pharmacy benefit managers (PBMs). Such deals have enabled the therapy to reach about 26 million patients, highlighting the company's interest in expanding its manufacturing capabilities.

“Celltrion is considering expanding manufacturing facilities abroad, as it will be crucial for securing production capacity and ensuring a sustainable future,” a spokesperson for the company told BioProcess insider. “[The company] is proactively expanding its production infrastructure to increase the supply of pharmaceuticals.”

“Our biopharmaceutical production plant in Songdo, Incheon, [South Korea] was the first in Asia to receive cGMP certification from the [US Food and Drug Administration] FDA for its animal cell-culture facilities in December 2007,” the spokesperson said. “This plant is fully equipped to produce both drug substances and finished drug products.”

With the 2024 completion of its third manufacturing plant, the company has achieved total in-house domestic production capacity of 252,000 liters for biopharmaceuticals.

Celltrion also has relationships with contract development and manufacturing organizations (CDMOs) in Singapore, the US, and elsewhere, enabling it to maximize production efficiency and biopharmaceutical capacity.

The spokesperson said that the company intends to operate its own CDMO facilities through a wholly-owned subsidiary, enabling it to develop and produce drugs for other companies. “Moving forward, we plan to continuously expand our production facilities to meet the growing demand for biopharmaceuticals.”

The FDA first approved Zymfentra in October 2023 through a Biologics License Application (BLA). The drugs, a biosimilar version of Janssen's Remicade, is the first FDA-approved subcutaneous infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.

"Our extensive engagement with PBMs and health plans from the outset have led to the comprehensive expanded access for Zymfentra in a short time frame," said Thomas Nusbickel, chief commercial officer (CCO) of Celltrion USA. "This achievement underscores Zymfentra's unique and innovative therapeutic advantages, and we look forward to expanding our outreach to deliver its treatment benefits to as many patients in the US as possible."

“Looking ahead, the company believes the availability of Zymfentra will support greater patient access and choice while helping to drive greater affordability to patients and health care systems,” the spokesperson told us. “We will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for US patients.”

Celltrion USA is the New Jersey-based subsidiary of South Korean biopharmaceutical company Celltrion.