Celltrion Inc

The FDA has approved expanded pediatric indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include adolescent hidradenitis suppurativa (ages 12+) and pediatric uveitis (ages 2+).

Celltrion's biosimilar Steqeyma has received regulatory approval from New Zealand's MEDSAFE, becoming the first Stelara biosimilar approved in the country for treating autoimmune diseases.

Hikma Pharmaceuticals and Celltrion Inc. have signed exclusive licensing agreements to bring six biosimilar treatments to the Middle East and North Africa region.

Celltrion has become the first pharmaceutical company to launch Omlyclo, an omalizumab biosimilar referencing Xolair, in the European market starting with Norway.

Celltrion's EYDENZELT (aflibercept-boav) becomes the first FDA-approved biosimilar to EYLEA for treating multiple retinal diseases including wet AMD, diabetic macular edema, and diabetic retinopathy.

Celltrion launched two biosimilars in Vietnam in 2024, including Remsima for autoimmune diseases and Herzuma for breast and stomach cancer.

The ulcerative colitis treatment market reached $8.4 billion across seven major markets in 2023, with the United States accounting for $5.9 billion of total revenue.

The FDA approved tocilizumab-anoh (Avtozma) IV formulation on August 6, 2025, for treating cytokine release syndrome in patients aged 2 years and older.

Amgen and Accord BioPharma reached a settlement agreement on July 16, 2025, resolving patent litigation over Accord's denosumab biosimilar INTP23, with Accord agreeing to delay U.S. market entry until October 1, 2025.

Celltrion has been named the preferred bidder for a large-scale biologics manufacturing facility in the US, with a final agreement expected in early October.