FDA approves Inflectra, the first biosimilar MAb in the USA

6 April 2016

The US Food and Drug Administration yesterday approved Inflectra (infliximab-dyyb) for multiple indications. This is the second biosimilar approved by the FDA and the first biosimilar monoclonal antibody (MAb) medication cleared in the USA.

South Korean biopharmaceutical company Celltrion’s (Kosdaq: 068270) Inflectra is biosimilar to US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech’s Remicade (infliximab), which was originally licensed in 1998. Remicade generated sales of around $4.5 billion for J&N last year. Pharma giant Pfizer (NYSE: PFE), through its Hospira business, has exclusive commercialization rights to the biosimilar in the USA.

In the USA, Inflectra, which is administered by intravenous infusion and is already cleared for marketing in more than 70 countries, is approved and can be prescribed by a health care professional for the treatment of:

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