FDA OKs Biosimilar to Etanercept for Inflammatory Diseases


August 30, 2016

The US Food and Drug Administration (FDA) today approved etanercept-szzs (Erelzi, Sandoz), a biosimilar to etanercept (Enbrel, Amgen) for rheumatoid arthritis and other inflammatory diseases.

The biosimilar to etanercept is a tumor necrosis factor blocker that is administered subcutaneously. The FDA defines biosimilars as very much akin to biological drugs and generally derived from a living organism. Biosimilars must demonstrate that they are just as safe and effective as their reference product. The FDA does not consider biosimilars as interchangeable with reference products, however.

Etanercept-szzs is indicated for the same inflammatory disorders as etanercept:

  • Moderate-to-severe rheumatoid arthritis, either as a standalone therapy or together with methotrexate

  • Moderate-to-severe polyarticular juvenile idiopathic arthritis in patients aged 2 years or older

  • Active psoriatic arthritis, including use in combination with methotrexate in patients with psoriatic arthritis who do not respond adequately to methotrexate alone

  • Active ankylosing spondylitis

  • Chronic, moderate-to-severe plaque psoriasis in patients aged 18 years or older who are candidates for systemic therapy or phototherapy

Infections and injection-site reactions are the most common adverse events expected with etanercerpt-szzs, the FDA said in a news release. Other serious adverse events anticipated by the agency are neurologic events, congestive heart failure, and hematologic events.

The new drug comes with a boxed label warning that alerts prescribers and patients to an increased risk for serious infections such as tuberculosis that could lead to hospitalization or death. The boxed warning also states that children treated with tumor necrosis factor blockers such as etanercept products have developed lymphoma and other malignancies, and that some have died.

The impetus for developing biosimilars such as etanercept-szzi is that they are less expensive than the reference drugs, and therefore more accessible to patients. However, "it is too early to speculate about the price of Erelzi, Sandoz spokesperson Elizabeth Renz told Medscape Medical News. "That being said, we believe patients in the US can benefit greatly from a competitively priced etanercept manufactured in accordance with strict (good manufacturing practices) and high quality standards."

Etanercept-szzs is not going on the market right away, and it's not clear if or when that will happen. Amgen, the maker of etanercept, filed a patent infringement suit against Sandoz earlier this year in a federal district court in Newark, New Jersey, in an attempt to keep the biosimilar off the market. On August 11, US District Judge Claire Cecchi issued a preliminary injunction — agreed to by both sides — that bars the manufacture or commercialization of etanercept-szzs. The terms of the agreement are under seal. The court case is scheduled to go to trial in April 2017.

More information about today's FDA approval of etanercept-szzi is available on the agency's website.

Follow Robert Lowes on Twitter @LowesRobert


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