FDA Clears Second Remicade Biosimilar

The US Food and Drug Administration (FDA) has approved the infliximab biosimilar product infliximab-abda (Renflexis, Samsung Bioepis) for multiple indications.

Infliximab-abda is the second FDA-approved biosimilar to the US-licensed reference product Remicade (Janssen Biotech Inc). The agency approved Inflectra (infliximab-dyyb) from Celltrion in April 2016.   

A biosimilar product is based on a showing that it is "highly similar" to an already approved biological reference product, the FDA notes. Biosimilars must also demonstrate no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Infliximab-abda, a tumor necrosis factor (TNF) blocker, is an intravenous infusion (100 mg) indicated for Crohn's disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. These are the same indications as original infliximab.

The most common adverse reactions (>10%) seen with infliximab-abda are infections (eg, upper respiratory infection, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain, which are similar to those seen with original infliximab.

Infliximab-abda at doses greater than  5 mg/kg is contraindicated in patients with moderate to severe heart failure and in patients with previous severe hypersensitivity reaction to infliximab products or known hypersensitivity to inactive components of infliximab-abda or to any murine proteins.

Infliximab-abda comes with the same boxed warning as its predecessor. The drug increases the risk for serious infections, such as tuberculosis, leading to hospitalization or death. Clinicians first should test patients for latent tuberculosis and, if it is found, treat it before administering infliximab-dyyb. Lymphomas and other malignancies have been reported in children and adolescents receiving infliximab products and other TNF blockers. There have been postmarketing cases of fatal hepatosplenic T-cell lymphoma in certain patients.

The full prescribing label is available on the FDA site.


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FDA Clears Second Remicade Biosimilar (Renflexis). Medscape. April 24, 2017.

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