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Renflexis FDA Approval History

Last updated by Judith Stewart, BPharm on April 21, 2017.

FDA Approved: Yes (First approved April 21, 2017)
Brand name: Renflexis
Generic name: infliximab-abda
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

The FDA approval of Renflexis is based on clinical safety and effectiveness data that demonstrates Renflexis is biosimilar to Remicade.

Renflexis is administered by intravenous infusion, usually at 0, 2 and 6 weeks, then every 8 weeks depending on the condition treated.

Renflexis comes with a Boxed Warning to alert health care professionals and patients of the increased risk of serious infections and malignancies. Common side effects include upper respiratory infections, sinusitis, infusion-related reactions, headache, and abdominal pain.

Development timeline for Renflexis

Apr 24, 2017Approval FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
May 23, 2016Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.