FDA Panel Recommendation On Arthritis Drug Knockoff Could Clear Way For More Biosimilars
The non-binding approval of the lower-cost version of Johnson & Johnson's drug Remicade could signal the FDA will use looser criteria for marketing approval than some people expected, analysts say. In other national news, The Wall Street Journal looks at how Sanofi's inhalable insulin missed the mark, Centene posts profits helped by its Medicaid business, the U.S. considers Medicare payment changes and the opioid crisis makes pharmacists play drug cop.
The Wall Street Journal:
Panel Recommends FDA Approval Of Remicade Knockoff
A U.S. regulatory panel vote on Tuesday is a win for companies developing lower-cost copies of pricey biotechnology drugs, but it could be a while before patients see them. An advisory panel to the Food and Drug Administration voted to recommend the agency approve the sale of a knockoff version of Johnson & Johnson’s arthritis drug Remicade, which had U.S. sales of $4.45 billion last year. The copy was developed by Celltrion Inc. and licensed to Pfizer Inc. (Loftus, 2/9)
The Wall Street Journal:
How A Sanofi Diabetes Bet Went Wrong
The history of inhalable insulins for diabetes care is full of disappointments, but Sanofi SA thought a new approach would turn all of that around. It was wrong. The French drugmaker last month ended a licensing pact with MannKind Corp. for the rights to sell the insulin inhaler Afrezza, saying that despite substantial marketing efforts, the product was unlikely to reach even the lowest patient levels anticipated. Sanofi’s bet on inhaled insulin shows the strain pharmaceutical chiefs are under to acquire innovative products when their own pipelines aren’t delivering. (Roland and Bisserbe, 2/9)
The Wall Street Journal:
Centene Profit Continues To Grow With Membership
Centene Corp., a Medicaid-focused health insurer, reported its profit rose 5.7% in the final quarter of the year as a key measure of the company’s medical costs fell and the company boosted its number of managed care members, but it also lowered its guidance for the year.The company said that its Medicaid business grew 30% to include 3.5 million members. (Steele, 2/9)
Bloomberg:
Medicare Weighing Changes To Doctor Drug Payments, Memo Shows
The U.S. is mulling changes to how the Medicare program pays physicians for administering expensive cancer drugs and other medications given in doctors’ offices, according to a memo from the Centers for Medicare and Medicaid Services. The memo tells Medicare contractors who process payments to set up a system allowing the government to vary by geographic location how much it reimburses doctors for the drugs they administer. The government could then set up a pilot program to test how limiting reimbursement in Medicare Part B, which pays for seniors’ medical services and supplies, affects doctors’ choice of drugs, according to the memo that was posted on the CMS website. (Tracer and Damouni, 2/9)
STAT:
Opioid Crisis Puts Pharmacists On The Front Line, Pressed To Serve As Drug Cops
From behind their counters, pharmacists are increasingly, and controversially, called upon to play drug cop — to turn away abusers, to reject phony prescriptions, and to protect their inventory of pills from criminals who see pharmacies as an easy target. (Glionna, 2/10)