Biosimilar Renflexis Gets FDA Approval
The Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda for injection; Samsung Biopesis), the second approved biosimilar to Remicade (infliximab; Janssen). Inflectra (infliximab-dyyb; Pfizer) was approved by the FDA in April 2016. A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product. Minor variations in clinically inactive components are allowed in biosimilar products.
Like Remicade, Renflexis is a tumor necrosis factor (TNF) blocker indicated for Crohn's disease, pediatric Crohn's disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatric arthritis, and plaque psoriasis.
Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. They inhibit the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells
Renflexis will be available in single-dose vials containing 100mg of lyophilized infliximab-abda for final reconstitution volume of 10mL.
For more information call (877) 888-4231 or visit Samsungbioepis.com.