FDA Approves Enbrel Biosimilar

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

The move is no surprise given the unanimous backing of an FDA advisory arm last month. There are now three FDA-approved biosmilars. Exactly when any of these drugs will be on the market is unclear due to patent disputes. 

The new approval is the largest marketed drug targeted to date by an FDA-approved biosimilar, FierceBiotech reports.

Erelzi is administered by injection for the treatment of active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone; chronic moderate-to-severe plaque psoriasis in adult patients (18 years or older); 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 and active ankylosing spondylitis.

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.

The most serious known side effects with Erelzi are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions with Erelzi are infections and injection site reactions. Erelzi should not be administered to patients with sepsis.

Erelzi contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including etanercept products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

Erelzi is manufactured by Sandoz Inc., based in Princeton, New Jersey, at Novartis Pharma in Stein, Switzerland. Enbrel is manufactured by Amgen Inc., of Thousand Oaks, California. 

There may, however, be a glitch in the road. This March, Amgen hit Sandoz with a patent infringement suit, stating that the company was “piggybacking on the fruits” of its “trailblazing efforts” with Enbrel. Amgen asked the U.S. District Court for the District of New Jersey to grant an injunction to block Erelzi sales, FierceBiotech reports. Stay tuned.