Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA®? (ustek inumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.

ZYMFENTRA blocks the action of tumorrosis 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 the351 (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.

Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls.

ZYMFENTRA, the most common adverse reactions occurring in 3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Globally, prescribing information varies; refer to the individual country product label for complete information. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries.

Such risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data and further analyses of new clinical data and further analyses.