The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL. The case had been administratively stayed since January 2020. Judgment…
July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Actemra® has been approved in the United States for the…
In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars. Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab). Pfizer also…
Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after…
This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…
The U.S. health insurance provider Cigna has provided a financial incentive to patients who switch to an infliximab biosimilar, through a one-time $500 debit card for health care services and products called the “Shared Savings Program.” Cigna has promoted this program as a way to promote biosimilar use and reduce…
On Thursday Theramex announced that it has entered into an agreement to register and commercialize denosumab, a biosimilar of Enzene Bioscience’s Prolia®, which treats osteoporosis by decreasing bone absorption. The agreement licenses Theramex to market the drug for use in Europe and Australia. Enzene will exclusively supply the finished product…
In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition. The white paper studied the price and…
Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Henlius stated that this is its third biosimilar approval in China, following approval of its rituximab and trastuzumab biosimilar products. Celltrion…