The U.S. Food and Drug Administration has approved its second-ever “biosimilar” drug, Inflectra, for adults with Crohn’s disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses.
In a media release, the agency said Inflectra was biosimilar to Janssen Biotech’s Remicade (infliximab), first licensed in 1998.
A biosimilar drug is sanctioned based on its maker’s ability to show that it is “highly similar” to an already-approved biological drug that is generally derived from a living organism, such as a person, animal, microorganism or yeast, the FDA said. The maker of a biosimilar drug also must prove that the product has no “clinically meaningful difference” in safety and effectiveness from the original drug, and that the newer product has only “minor differences in clinically inactive components” from the original.
Inflectra’s most common clinical side effects included respiratory infection, headache, cough and stomach pain. A less common but more severe side effect could include an allergic-like reaction within two hours of the drug’s injection, the FDA said.
In addition, Inflectra’s label will include a boxed warning that the drug could lead to a deadly infection such as tuberculosis, sepsis (blood infection) or fungal infection. The warning also says some deadly cancers have been reported in children and teens who used infliximab or similar drugs.
The first biosimilar drug, approved in 2015, was Sandoz’s Zarixo, which is biosimilar to Amgen’s Neupogen, designed to boost white blood cells.
Inflectra is produced by the Korean drugmaker Celltrion for Lake Forest, Ill.-based Hospira.
Visit the FDA to learn more.
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