Celltrion

JERSEY CITY, N.J., April 28, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Express Scripts, one of the nation's leading pharmacy benefit managers (PBMs) negotiating on behalf of health plans covering more than 100 million people. The agreement, effective April 4, 2024 provides ZYMFENTRA Preferred Brand Access on the Express Scripts National Preferred Formulary serving 21.9 Million insured lives. Express Scripts provides plan participants such as Health Plans of the PBM the ability to add ZYMFENTRA™ (infliximab-dyyb) to their formularies.

"This agreement opens up an important pathway for access to treatment for millions of patients with chronic diseases," said Francine Galante, Vice President of Market Access at Celltrion USA. "We will continue to work with providers, patients and physicians to build upon our mission of developing transformational therapies that meet the needs of our patients living with chronic debilitating pain."

Celltrion's ZYMFENTRA, the first and only FDA-approved subcutaneous infliximab is now commercially available in the U.S.

The company continues to engage with national and regional health plans, as well as Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs), to communicate the value of its FDA-approved therapies including ZYMFENTRA for patients with autoimmune disease and to secure broad coverage.

About Celltrion USA

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA^®(infliximab-dyyb), TRUXIMA^®(rituximab-abbs), HERZUMA^®(trastuzumab-pkrb), VEGZELMA^® (bevacizumab-adcd), and YUFLYMA^®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA 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 U.S. patients. For more information, please visit: www.celltrionusa.com/

About ZYMFENTRA™ (infliximab-dyyb)^[1]

ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.

ZYMFENTRA™ (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.

[1] Zymfentra Prescribing Information