On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. According to Merck’s press release, Renflexis® “will be introduced in the U.S. [at] . . . a 35 percent discount to the current list price” of the reference product. Renflexis® is the second FDA-approved commercially available biosimilar to Jansen’s Remicade® (infliximab) available in the United States. As we previously reported, the FDA approved Reflexis® in April of this year, and Janssen filed patent litigation (arising to the BPCIA) against Samsung in New Jersey in May 2017 based on the filing of the BLA.

The first FDA-approved infliximab biosimilar, Sandoz’s Zarxio®, was launched in September 2015. Litigation related Sandoz’s infliximab is also currently pending in New Jersey, as discussed in RFEM’s Litigation Spotlight series here and here.

View table

The approval dates and launch status of all FDA-approved biosimilars in the United States are shown in the table above. Two additional biosimilars, Amgen and Allergan’s bevacizumab and Mylan and Biocon’s trastuzumab, have been recommended for approval by the FDA’s Advisory Committee but have not yet been formally approved and licensed.