
FDA Approves Second Biosimilar to Remicade
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
On April 21, 2017 FDA announced that it approved Renflexis (infliximab-abda) a biosimilar to Janssen Biotech’s blockbuster Remicade (infliximab). This is the second approved biosimilar for Remicade-Celltrion’s Inflectra (infliximab-dyyb) was approved by the agency in early April 2016. Renflexis also marks the fifth FDA approved biosimilar.
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Remicade is a key product for Johnson & Johnson, and the approval of biosimilar competition like Renflexis and Inflectra may put a dent in J&J’s annual sales. In J&J’s
Source: FDA, Samsung Bioepis, Johnson & Johnson
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