South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Samsung Bioepis is months away from winning European clearance to market a copy of Amgen and Pfizer's blockbuster rheumatoid arthritis treatment Enbrel, securing a positive recommendation from EU regulators.
Amgen's knockoff of AbbVie's top-selling Humira measured up to its reference product in a Phase III trial, clearing the way for the Big Biotech as it waits for the blockbuster injection to lose patent protection next year.
A new pill from Eli Lilly and Incyte beat AbbVie's injectable Humira, the world's top-selling drug, in a Phase III rheumatoid arthritis trial, setting the stage for an FDA submission.
Samsung Bioepis has received South Korean approval for a biosimilar of rheumatoid arthritis drug etanercept, dubbed Brenzys, marking a first with a launch slated by the end of 2015 or early next year with commercial operations in partnership with Merck Sharp & Dohme, or MSD.
Yale scientists successfully tried out Pfizer's rheumatoid arthritis drug Xeljanz (tofacitinib) on a small group of people suffering from severe, treatment-resistant eczema, highlighting its added promise after the drug also demonstrated its potential in fighting two other skin conditions.
Belgium's Galapagos says that its oral JAK1 inhibitor filgotinib met its primary and other endpoints in a crucial Phase IIb study for rheumatoid arthritis.
The intravenous administration of monocytic myeloid-derived suppressor cells, or M-MDSCs, proved promising in treating rheumatoid arthritis in mice, inhibiting T cell proliferation, as well as B cell proliferation and antibody production.
Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.
The United Kingdom's National Institute for Health Research has teamed up with Johnson & Johnson's Janssen to figure out why anti-TNF drugs are ineffective in some rheumatoid arthritis patients. J&J is funding the collaboration, which is indicative of how the U.K. wants to embed its healthcare infrastructure in drug development.