FDA approves Remicade biosimilar
WASHINGTON — The Food and Drug Administration on Friday approved Renflexis (infliximab-abda) for multiple indications, the second FDA-approved biosimilar to Remicade. Renflexis is administered by intravenous infusion. Merck will market the drug, which will be developed by South Korea's Samsung Bioepis.
Remicade is manufactured by Johnson & Johnson.
According to the FDA, A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.