Renflexis FDA Approval History
Reviewed by J.Stewart BPharm. Last updated 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, 2017||ApprovalFDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade|
|May 23, 2016||Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade|
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