We are one step closer to a new generation of cheaper drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it
And Obamacare paved the way.


With the high cost of specialty drugs capturing so many headlines these days, here's a bit of a change of pace: A new wave of cheaper drugs marked a major milestone Thursday.


The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive. For example, some biologics to combat rheumatoid arthritis, a disease affecting about 1 percent of the adult population, can cost more than $5,000 a week.


While cheaper generics now dominate the U.S. market for traditional drugs, accounting for about 85 percent of all prescriptions, you still can't get another version of biologic drugs in this country. That's about to change, though, because of a provision included in the Affordable Care Act that provides a pathway for copycat biologics, known as biosimilars, to enter the U.S. market.


The biosimilars' potential for savings in the United States seems to be pretty huge. The pharmacy benefits manager Express Scripts, which has actively advocated for more rapid adoption of biosimilars, estimates that the United States would save $250 billion in health-care spending over the next decade if just 11 biologics had biosimilar alternatives.


Thursday's FDA application from Sandoz is just the first step. The company, which already markets its biosimilar in 40 countries, could gain final FDA approval as early as the first quarter of 2015, according to the Avalare Health consulting firm. With so much concern from health-care payers over a projected rise in U.S. drug spending in the next few years, the development of domestic biosimilar market is something worth watching