Generic insulin, cancer therapies? They’re coming

Even as Republican presidential candidates vow to dismantle what they call “Obamacare” -- the Patient Protection and Affordable Care Act of 2010 -- some of the law’s key provisions are making their way onto the medical landscape. The latest step toward implementing the law came Thursday, as the Food and Drug Administration issued draft rules that will open the U.S. marketplace to “biosimilars” -- essentially generic versions of medications made with living, often bioengineered, organisms.

The FDA’s actions Thursday promise U.S. consumers the prospect of big savings and some uncertainty too, as generic drug manufacturers and biotechnology firms -- many of them outside of the United States -- begin to make and market these complex medications.

Lawmakers who drafted the measure were told that opening this specialty-drug market to new manufacturers could drive down prices for such widely-used medications as insulin, anti-retroviral drugs, interferon, infertility medications and certain cancer therapies by 25% to 45%, slashing the nation’s healthcare spending by $25 billion over 10 years.

But whether these less-expensive biosimilars will work as well as the brand-name drugs they mimic is not a simple matter. These medications result when living organisms are genetically engineered to produce specialized proteins that in turn have a cascade of complex effects inside the body. Small manufacturing changes would make a copy-cat medication quite different from the original. Compared to generic drugs, they’re trickier to produce and pose more safety issues for patients who take them.

So it’s up to the FDA, the law says, to assure that there are “no clinically meaningful differences” between the original, branded medication and the biosimilar product that mimics it. To do that, the FDA -- which has its hands pretty full with food safety initiatives and other regulatory concerns -- has asked for millions more from Congress at a time when budgets are being slashed.

The rules released for public comment on Thursday lay out how the FDA will require companies to demonstrate that their proposed biosimilars have the same effects on patients as the original medications. The FDA has said that in some cases, it may not require that clinical trials be conducted on the proposed biosimilar as proof of its effectiveness. FDA officials, saying they would not impose a “one-size-fits-all” approach to regulating these drugs, said that once a firm seeks approval to make a biosimilar, it would work with that firm to lay out what tests would be required.