Earlier this week, the U.S. FDA approved Samsung Bioepis’s HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…
On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year. According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…
Yesterday, Immunex, Amgen, and Hoffmann-LaRoche (collectively, “Plaintiffs”) filed a complaint in the District of New Jersey against Samsung Bioepis alleging patent infringement under the BPCIA based on Samsung Bioepis’ submission of an aBLA for a biosimilar of ENBREL® (etanercept). As we reported yesterday, Samsung Bioepis recently received FDA-approval for that product,…
As we have reported, Samsung Bioepis is engaged in U.S. patent litigation and proceedings against Genentech in connection with Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb) biosimilar product, which the U.S. FDA approved earlier this year. In addition to litigating a BPCIA case in federal district court that is currently scheduled for a…
Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…
During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future. Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate On January 14, 2019, Bio-Thera Solutions Ltd announced that it has entered into a licensing agreement with Cipla Limited for BAT-1706, its…
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to…
United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.” According to the Senators, “biologics constitute a…
Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized, double-blinded studies compared the safety and efficacy of BENEPALI (SB4, etanercept biosimilar); FLIXABI (SB2, infliximab biosimilar); and IMRALDI (SB5,…
According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…