FDA Accepts Samsung Bioepis’s BLA for Remicade® Biosimilar

Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis.

Remicade® had over ten billion dollars in sales in 2014. As previously reported here, sales have suffered from increased biosimilar competition in Europe, and the FDA recently approved Celltrion’s Inflectra, another Remicade® biosimilar. (For information on Celltrion’s litigation with Janssen over patents covering Remicade®, see here.)

In its press release, Samsung Bioepis noted that it has thirteen other potential biosimilar candidates in its pipeline, including biosimilars of blockbusters like Humira® and Enbrel®.

Big Molecule Watch will continue to track biosimilar activity at the FDA, so check back for the latest news and analysis.