The use of biosimilars for rheumatology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…
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The ACR Continues Fight to Block Medicare Part B Demo Project: Rule Expected in Fall 2016
The ACR will seek Congressional action if the Medicare Part B demonstration project proposed by the Centers for Medicare & Medicaid Services (CMS) is not significantly altered by the agency. Today, Medicare Part B generally pays physicians and hospital outpatient departments the average sales price of a drug, plus a 6% add-on, minus reductions required…
Biosimilars Debate Heats up over Cost Savings, Safety Concerns
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Market Turmoil Drives Small Biotechs to Big Pharma
(Reuters)—Numerous small biotechnology companies have been all but shut out of the capital markets, leaving many with no choice but to consider a sale to larger peers. The Nasdaq Biotech Index is down nearly 30% since September, when Democratic presidential candidate Hillary Clinton criticized drug companies’ “price gouging” on Twitter and sparked concerns about a…
Newly Released Documents Show Profit-Seeking Behind Price Hikes at Turing, Valeant
WASHINGTON/NEW YORK (Reuters)—A decision by Turing Pharmaceuticals to raise the price of a lifesaving drug by 5,000% drove up some patient co-pays to as high as $16,000, according to excerpts of documents that congressional committee members released on Tuesday. The excerpts, which are highlighted in memos released by Democrats on the powerful U.S. House of…
Looking Back on Rheumatology in 2015, Leaping Forward to the Year Ahead
My dear friends, we come to praise Caesar. As we march toward 2016, we ought to acknowledge the great Roman emperor’s role in creating a proper calendar. At the start of Caesar’s reign, the calendar year lasted 355 days, 10¼ days fewer than the time it took the earth to fully orbit the sun.1 Although…
Anthem to Buy Cigna to Create Biggest U.S. Health Insurer
(Reuters)—Anthem Inc. said on Friday it would buy Cigna Corp. in a deal valued at $54.2 billion, creating the largest U.S. health insurer by membership. The deal—the biggest ever in the health insurance industry—comes three weeks after Aetna Inc agreed to buy Humana Inc for $37 billion and is part of an industry-wide consolidation following…
After Default, Fight Breaks Out Over Greek Medicine Supplies
LONDON (Reuters)—Wholesalers trading medicines across European borders have criticized a suggestion by manufacturers that Greek exports should be restricted to prevent shortages of life-saving drugs in the country. Such trade, which allows traders to buy products in low-cost markets and sell them where prices are higher, is allowed under EU free trade rules. But drugmakers…
Greece’s Medicine Supply May Be in Jeopardy
BASEL, Switzerland (Reuters)—Drugmakers said on Monday they would continue to ship medicines to Greece in coming weeks, despite mounting unpaid bills, but warned supplies could be in jeopardy if Europe did not take emergency action. “In the worst-case scenario of ‘Grexit’, we believe the integrity of the medicines supply chain may be in jeopardy, which…