FDA approves Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.

Erelzi is administered by injection for the treatment of:

• moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
• moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
• active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
• active ankylosing spondylitis (an arthritis that affects the spine); and
• chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product.