Perspectives: Interchangeability Requirements Misguided And Counterproductive To Fostering Biosimilars

Stat: Inappropriate 'Interchangeability' Requirement For Biosimilars Will Cost The U.S. Billions
As a way to rein in the staggering amount of money that Americans spend on the complex drugs known as biologics each year, creating biosimilars as less-expensive alternatives makes sense. Europe has already approved 43 biosimilars; the U.S. just 11 of them. The U.S. will continue to lag behind in the development and use of biosimilars if Congress and the FDA require the “interchangeability” label for pharmacy substitution of reference biologics. (Vijay Ramakrishnan and Edwin P. Ching, 9/4)

The Hill: Biosimilar Medicines Are The Key To Success
The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis and Crohn’s disease — depend on safe and effective biological medicines called tumor necrosis factor (TNF) inhibitors. These are highly effective but can cost as much $48,000 annually for a single patient. (Angus B. Worthing, 9/3)

Bloomberg: Hedge Funds’ Big Bet On Health Care May Backfire
It’s not quite the big short, but the latest outsized bet by hedge funds suggests the highly paid managers are worried that the economy’s good health may falter soon. Hedge funds, which until recently have been overweight technology stocks, particularly the popular FANG members, in addition to the consumer discretionary sector, have shifted their assets into health care. It’s typically a sector that’s less sensitive to moves in the economy than, say, tech or consumer discretionary, and it’s a place investors turn to for protection when they are worried the market might head south. (Stephen Gandel and Max Nisen, 8/30)

Forbes: Big Data Is Remaking Big Pharma
Big Pharma is in a rut. The industry keeps spending more and yet making fewer scientific breakthroughs. But help is on the way. (Jon Markman, 8/30)