FDA Approves Biosimilar to Etanercept

August 31, 2016

Etanercept-szzs (Erelzi, Sandoz) has been approved by the U.S. Food and Drug Administration for RA and more.

Etanercept-szzs (Erelzi, Sandoz) has been approved by the U.S. Food and Drug Administration for all indications of the reference product:  rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

This is the second FDA-approved biosimilar for Sandoz, a division of Novartis. The first, filgrastim-sndz (Zarxio injection), was approved by the FDA in 2015 and entered the market in September. Filgrastim-sndz, a biosimilar of Neupogen, is recommended for cancer patients for a number of uses from preventing infection to neutrophil recovery.

Satisfied that multiple clinical studies have shown that the etanercept biosimilar is highly similar to the reference product, back in July, an FDA advisory committee recommended the approval of the etanercept biosimilar.

A study published in the August issue of BioDrugs, showed that a biosimilar to etanercept was “a therapeutically equivalent alternative in adult patients with autoimmune inflammatory diseases requiring treatment with etanercept.”

Boxed Warning Label

The most serious known side effects with Etanercept-szzs  are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions are infections and injection site reactions.

Etanercept-szzs will come with a boxed warning about the 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.

Indications

·        Moderate to severe rheumatoid arthritis. Etanercept-szzs has been shown to prevent the deterioration of further joint damage. It can be taken with or without methotrexate.

·        Moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). It has been approved to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.

·        Psoriatic arthritis. Reduce the signs and symptoms of PsA and to prevent further joint damage. It can be used with or without methotrexate in patients who do not respond adequately to methotrexate alone.

·        Ankylosing Spondylitis (AS). It is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

·        Moderate to severe plaque psoriasis. It is approved to treat adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

 

 

References:

Celeste B. Burness, Sean T. Duggan. "Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases," BioDrugs. Online first July 25, 2016. DOI: 10.1007/s40259-016-0188-z

 

"FDA approves Erelzi, a biosimilar to Enbrel," FDA news release. Aug. 30, 2016.