(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
FDA Greenlights Osteoporosis Drug for Postmenopausal Women
(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…
U.S. Top Court Debates Making Copycat Biologics Available Sooner
WASHINGTON (Reuters)—U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers. The nine justices heard arguments in an appeal by Novartis AG of a lower court…
U.S. Supreme Court Declines to Hear Biologic Drug Patent Fight
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market. The justices opted not to take up Apotex Inc.’s appeal of a July federal appeals court ruling that could…
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…
FDA Panel Supports Novartis Biosimilar of Etanercept
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira
(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
U.S. Patent Office Rules Against Amgen Humira Challenge
(Reuters)—U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira (adalimumab), a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that…
Amgen Files for U.S. Approval of Biosimilar
(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Novartis Biosimilar Takes Aim at Amgen’s Enbrel
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…