FDA Advisory Panel Backs First Potential ‘Copycat’ Drug
If the government accepts the recommendation, it could mean millions of dollars in savings for consumers who need expensive drugs.
The Washington Post:
A Class Of Expensive Drugs Is Getting Cheaper Competition For The First Time
A government panel Wednesday took a major step toward approving a copycat version of a blockbuster cancer drug, paving the way for a new class of cheaper medicines that could save consumers billions of dollars. An expert Food and Drug Administration panel unanimously recommended that the government approve the drug known as EP2006, a lower-cost imitator of a popular medicine called Neupogen, used to help cancer patients fight off infection while undergoing chemotherapy. The FDA usually accepts recommendations from advisory panels but is not required to. (Millman, 1/7)
The Wall Street Journal:
FDA Panel Backs First ‘Biosimilar’ Drug
A U.S. Food and Drug Administration advisory panel on Wednesday unanimously recommended the agency approve the first “biosimilar” drug in the U.S., a version of the anti-infective cancer drug Neupogen. The FDA panel concluded by a vote of 14-0 that a drug called EP2006, which Novartis AG ’s Sandoz unit plans to market in the U.S. under the name Zarxio, is highly similar to Amgen Inc. ’s Neupogen. Neupogen is designed to increase white blood-cell counts, and lower infection rates, mostly in patients getting chemotherapy and other treatments. (Burton, 1/7)
FDA Advisers Back First Potential Copycat Biotech Drug In U.S.
A Food and Drug Administration advisory panel on Wednesday voted to recommend that the agency approve a generic version of a biotech drug, a move that could lead to the first U.S.-approved “biosimilar” in a potentially booming market. The panel voted 14 to 0 to recommend approval of a generic version of Neupogen, a $1.4 billion drug produced by Amgen Inc. used to boost white blood cells in cancer patients. Novartis AG’s Sandoz unit submitted its application earlier this year. (Gustin and Young, 1/7)
Meanwhile, other media look at how drug companies market to doctors and hold onto patents -
Vying For Market Share, Companies Heavily Promote ‘Me Too’ Drugs
For more than five decades, the blood thinner Coumadin was the only option for millions of patients at risk for life-threatening blood clots. But now, a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country. The manufacturers of these drugs — Pradaxa, Xarelto and Eliquis — have been wooing physicians in part by paying for meals, promotional speeches, consulting gigs and educational gifts. In the last five months of 2013, the companies spent nearly $19.4 million on doctors and teaching hospitals, according to ProPublica's analysis of federal data released last fall. The information, from a database known as Open Payments, gives the first comprehensive look at how much money drug and device companies have spent working with doctors. What it shows is that the drugs most aggressively promoted to doctors typically aren't cures or even big medical breakthroughs. Some are top sellers, but most are not. (Ornstein and Jones, 1/7)
U.S. Hedge Fund Plans To Take On Big Pharma Over Patents
U.S. hedge fund manager Kyle Bass, who won fame for predicting the subprime mortgage crisis in 2008, plans to take on some of the world's biggest drug producers by challenging the patents of their top brands, he said on Wednesday. Bass, the founder of Dallas-based Hayman Capital Management, L.P., said some drug firms were hanging onto patents in questionable ways and he planned to take around 15 firms into a so called Inter Partes Review (IPR) process created by the America Invents Act in 2012. (1/7)