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

Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson,   (“Janssen” or “Plaintiff”) filed a Complaint in the United States District Court for the District of New Jersey against Samsung Bioepis Co., Ltd. (“Samsung Bioepis” or “Defendant”),  a joint venture between Samsung Biologics and Biogen.  The patent infringement litigation relates to Samsung Bioepis’s

FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017.  Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®.  Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and