To substitute or not to substitute? Biotechs and biosim makers compromise on legislation

Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.

Ralph Neas--Courtesy of GPhA

The parties have agreed to support state legislation that allows pharmacies to automatically substitute biosimilars for corresponding branded biologics. But pharmacies must give prescribers a heads up afterward "within a reasonable time." For biosimilars makers, it's a big improvement on the alternative; biotech developers at one point wanted to require pharmacists to check with doctors before making the switch.

"This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines," GPhA President and CEO Ralph Neas said in a statement.

Of course, biosimilars makers are still a long way off from their chance to steal market share from some of the world's best-selling branded products. The FDA has yet to determine exactly how to classify biosimilars and their "reference products" as interchangeable, a classification that's necessary for those pharmacy switches.

And to this point, only a couple of biosimilars have been submitted for FDA review--a copy of Amgen's ($AMGN) white blood cell booster Neupogen from Novartis' ($NVS) Sandoz, and a biosimilar version of Johnson & Johnson's ($JNJ) blockbuster anti-inflammatory Remicade from South Korea's Celltrion.

Novartis CEO Joe Jimenez

The remaining snags led Novartis CEO Joe Jimenez to predict this summer that biosimilars won't really make too big a splash in the next two or three years. That's despite lower prices that could save the U.S. healthcare system billions of dollars over the next decade, experts say.

But come 2020, when a host of pricey biologics are set to lose patent protection? "You're going to see a big impact," he said.

- read the compromise language (PDF)
- see the GPhA release

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