The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…
A paper published in the Generics and Biosimilars Initiative Journal reports on “an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy.” The paper, which was based on studies funded by the Italian Ministry of Health,…
The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the…
As we previously reported, on September 20, 2017, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product. On November 28, 2017, J&J filed…
The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding…
Last week, Johnson & Johnson held its earnings call for the fourth quarter of 2017. During the call, company representatives discussed an 8% decline in U.S. sales for Remicade as Johnson & Johnson “continued to compete in the phase of biosimilar entries.” As we previously reported, there are two biosimilars…
Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone. The facility, which is scheduled to open in the second half of 2018, will feature…
On January 15, 2018, Swedish company XBrane Biopharma issued a press release stating that, in December 2017, it signed a non-binding letter of intent with Chinese company CR Pharma regarding XLucane, a ranibizumab biosimilar. According to the press release, XBrane and CR Pharma intend to take Xlucane to market in China,…
Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of…
On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California. Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. According to the complaint, Celltrion and Teva seek a declaratory judgment of non-infringement, invalidity, and/or unenforceability of 38…