Victims of digestive disorders, arthritis and psoriasis are one step closer to relief as of April 5, when the U.S. Food and Drug Administration approved Inflectra to address Crohn’s, colitis, and other chronic ailments.
The multi-purpose medication is now the nation’s second approved biosimilar formula, administered intravenously, mirroring the branded Remicade manufactured by Janssen Biotech Inc. and licensed in 1998.
“Biosimilars can provide access to important treatment options for patients who need them,” Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”
Doctors can now prescribe Inflectra for both adults and children suffering from Crohn’s disease, ulcerative colitis; and rheumatoid, ankylosing (spinal) or psoriatic arthritis who have not responded favorably to conventional therapies.
“The FDA is taking important steps toward approving more biosimilars in the United States," Pharmaceutical Care Management Association President and CEO Mark Merritt said. "Increasing competition through the approval of brand and generic drug competitors is the key to lowering prescription drug costs for consumers, employers, government programs and others. To further advance the use of biosimilars, the FDA should finalize an interchangeability policy that will allow for greater patient access to these important drugs.”
In order to be sanctioned by the FDA, a biosimilar must display no significant differences in safety and efficacy from the product it is designed to mimic. By definition, a biosimilar is a biological product for which approval is based on proof that it is highly similar to an already-approved biological product, called the reference product.
The FDA reviewed evidence comprised of various data sets for functionality and safety, noting that Inflectra’s status is approved as a biosimilar but not necessarily interchangeable with its reference product.
Inflectra is manufactured by Celltrion Inc. for Hospira, of Lake Forest, Illinois.
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