HealthDay News — The US Food and Drug Administration (FDA) 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. Infusion reactions (including fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash, and itching) can occur within two hours of infusion, the FDA said.
In addition, Inflectra’s label will include a boxed warning that the drug could increase risk of serious infections leading to hospitalization or death, such as tuberculosis, sepsis, and invasive fungal infections.
The warning also says lymphoma and other malignancies, some fatal, have been reported in children and teens who used infliximab or similar drugs.
Inflectra is produced by the Korean drug manufacturer Celltrion for Lake Forest, Illinois-based Hospira.
FDA approves Inflectra, a biosimilar to Remicade. US Food and Drug Administration (FDA). http://www.nema.org/stds/halide-schools.cfm#download. Accessed April 07, 2016.