(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
Samsung Bioepis Humira Biosimilar Wins FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
Upadacitinib Monotherapy Effective in Refractory Rheumatoid Arthritis
NEW YORK (Reuters Health)—Monotherapy with the JAK1-selective inhibitor upadacitinib is effective in patients with active rheumatoid arthritis who have an inadequate response to methotrexate, according to results from the SELECT-MONOTHERAPY phase 3 trial. As many as two-thirds of patients with rheumatoid arthritis receiving methotrexate monotherapy fail to achieve satisfactory disease control. Oral therapy with upadacitinib…
Trio Wins Chemistry Nobel for Work on Antibody Drugs & Detergents
STOCKHOLM/LONDON (Reuters)—Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to generate novel proteins used in everything from environmentally friendly detergents and biofuels to cancer drugs. The fruits of this work include the world’s top-selling prescription medicine – the antibody injection Humira sold by…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…
AbbVie’s Rheumatoid Arthritis Drug Succeeds in Late-Stage Trial
(Reuters)—U.S. drugmaker AbbVie Inc said on Wednesday late-stage data showed its rheumatoid arthritis drug performed better than a placebo in reducing symptoms in moderate-to-severe patients who have not adequately responded to standard treatments. Two doses of the drug, upadacitinib, induced a statistically significant reduction in symptoms compared to a placebo in the 12-week long study,…
Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…