Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Approves Knockoff Version Of Johnson & Johnson's Remicade
The Associated Press: FDA Approves 1st Cheaper Version Of J&J’s Top Drug Remicade
Federal health officials have approved a cheaper version of Johnson & Johnson’s blockbuster drug, Remicade, a pricey biotech medicine for inflammatory diseases. The approval of Inflectra Tuesday is only the second time that the Food and Drug Administration has approved a quasi-generic biotech drug for the U.S. market. These so-called biosimilar drugs, already available in Europe, have the potential to generate billions of dollars in savings for insurers, doctors and patients in coming years. (Perrone, 4/5)
The Wall Street Journal: FDA Approves Rheumatoid Knockoff
Inflectra is what regulators and the drug industry call a “biosimilar” to J&J’s Remicade, which has been available since 1998 and had U.S. sales of $4.45 billion last year. A biosimilar is a close copy of a biotech drug, which is usually manufactured in living cells rather than synthesized chemically like traditional pills. The FDA last year approved the first biosimilar—a Novartis AG version of Amgen’s Neupogen drug for cancer chemotherapy patients—using new criteria arising from a provision of the 2010 Affordable Care Act aimed at supporting a biosimilar market. (Loftus, 4/5)
In other pharmaceutical news —
The Associated Press: Valeant Completes Accounting Review, Finds No New Issues
Valeant said Tuesday that it has completed a review of its accounting and found no new problems. Shares of the troubled Canadian drug company soared Tuesday morning. Valeant is facing several problems, including federal probes into its accounting and business practices. Last month, the company said longtime CEO J. Michael Pearson was leaving the company once a successor is chosen. (4/5)
