FDA Approves First Biosimilar Drug
By giving its OK for the first time to a so-called biosimilar drug, the Food and Drug Administration cleared the way for less costly alternatives to an entire class of complex and costly drugs.
The Wall Street Journal:
U.S. Clears First Copycat Biotech Drug, Jolting Sector
The Food and Drug Administration approved the first copy of a biotechnology drug for the U.S. market, firing the starting gun on a new industry that could help the U.S. curb its $376 billion in yearly drug spending. The drug is a rival version of Neupogen, an Amgen Inc. treatment prescribed to chemotherapy patients. The copycat medicine, Zarxio from Novartis AG , is the first approved under a new regulatory framework designed to introduce competition for costly biotech drugs, which are produced in living cells and typically administered by infusion or injection. (Rockoff and Loftus, 3/6)
The New York Times:
F.D.A. Approves Zarxio, Its First Biosimilar Drug
The Food and Drug Administration has approved the first so-called biosimilar drug for use in the United States, paving the way for less expensive alternatives to an entire class of complex and costly drugs. The drug, called Zarxio, produced by Sandoz, is used to help prevent infections in cancer patients receiving chemotherapy. It is a close copy of an existing medication called Neupogen, made by Amgen. It was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because no regulatory pathway existed to bring biosimilars — approximate copies of drugs in a class known as biologics — to market. (Tavernise and Pollack, 3/6)
The Washington Post's Wonkblog:
The FDA Just Approved A New Kind Of Drug That Could Pave The Way To Cheaper Medicine
Federal regulators on Friday approved the sale of the first-ever biosimilar drug in the United States, opening the door to a cheaper class of drugs that could expand patient access to life-saving treatments. The FDA approved Novartis AG's copycat version of Neupogen, a biologic cancer drug that recorded $1.2 billion in worldwide sales last year. Novartis already sells biosimilar versions of the drug in more than 40 countries, but Friday's announcement will allow the company to start selling the drug in the United States. (Millman, 3/6)
The Associated Press:
Patients Could Save Billions With First Lower-Cost Copy Of Biotech Drug
Federal health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients. Biotech drugs are powerful, injected medicines produced in living cells. They are typically much more expensive than traditional chemical-based pills. (Perrone and Johnson, 3/8)
The Hill:
FDA Approves First 'Biosimilar' Drug, Boosting Competition
The Food and Drug Administration on Friday approved the first "biosimilar" drug in the United States, in a move that is expected to increase competition and lower prices in the drug market. A biosimilar drug is the equivalent of a generic drug in that it copies an existing brand-name medication. But unlike generics, biosimilars are not exact copies. They are imitating much more chemically complex drugs that cannot be easily copied and come from living organisms, which makes them more unpredictable. (Sullivan, 3/6)
In other drug industry news -
Bloomberg:
Investors Warm To $100k Cancer Drugs After $21B Deal
President Barack Obama, prominent cancer doctors and health insurers are all warning about the need to control the surging prices of new drugs. Drugmakers and their investors aren’t acting worried at all, especially when it comes to cancer medicine. In the wake of AbbVie Inc.’s $21 billion pact to buy the maker of a $100,000-a-year leukemia drug, the pharmaceutical industry and Wall Street are signaling they don’t expect the brakes on pricing any time soon in the oncology field. (Langreth and Koons, 3/9)
