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October 23, 2023 : Celltrion USA has announced the U.S. Food and Drug Administration (FDA) approval of ZYMFENTRA® (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.
ZYMFENTRA is a biosimilar to Remicade®, a biologic drug used to treat IBD for over 20 years. Biosimilars are highly similar to biological drugs but are often more affordable.
ZYMFENTRA is administered subcutaneously or under the skin. This offers a number of advantages over intravenous (IV) administration, which is the typical route of administration for biological drugs. Subcutaneous administration is less invasive and can be done at home, improving patient convenience and quality of life.
In clinical trials, ZYMFENTRA was shown to be as safe and effective as Remicade for treating IBD.
The approval of ZYMFENTRA is a significant development for people with IBD. ZYMFENTRA is the first and only subcutaneous infliximab, which offers a number of advantages over IV administration.
ZYMFENTRA is also a biosimilar, which means that it is more affordable than Remicade. This will make infliximab treatment more accessible to people with IBD.
The approval of ZYMFENTRA is also a sign of the growing importance of biosimilars in the healthcare industry. Biosimilars are increasingly important in expanding access to affordable and high-quality biologic drugs.
The approval of ZYMFENTRA is a significant development for people with IBD. ZYMFENTRA is the first and only subcutaneous infliximab, which offers a number of advantages over IV administration. ZYMFENTRA is also a biosimilar, meaning it is more affordable than Remicade.
The approval of ZYMFENTRA is also a sign of the growing importance of biosimilars in the healthcare industry. Biosimilars are increasingly important in expanding access to affordable and high-quality biologic drugs.
