- - Thursday, December 26, 2013


The Federal Trade Commission (FTC) has started to meddle on a health issue that probably isn’t on the radar of more than a couple of health-policy wonks, but it should be of interest to anyone who treats patients or cares about patient safety.

It’s about a class of medicines called “biosimilars,” copycat versions of innovator biologics — or medicines made from living cells. Most people aren’t even familiar with biologics, let alone biosimilars. Biologics are the fastest-growing segment of the pharmaceutical industry and are primarily used to treat life-threatening or difficult-to-target diseases like cancer, diabetes, multiple sclerosis, lupus, Crohn’s disease, rheumatoid arthritis and epilepsy. Many people aren’t familiar with them yet and only know about traditional chemical compounds, which are vastly different.

Why is the FTC involved? Good question. The FTC’s interest here would be to ensure that “anti-competitive” or “deceptive practices” don’t compromise consumers’ ability to know which product he or she is prescribed, and to ensure it’s the one he or she actually receives. That’s because that’s what “informed consumer choice” is all about — right?

Not in this case. The issue the FTC is actually focusing on is whether any and all biosimilars that follow a particular “reference product” (the innovator biologic) ought to have the exact same name as that reference product. And all current indications point to the FTC is about to concur that they should.

This is no trivial issue. It is a fact that no two biologic products produced by different manufacturers will be the same. A biosimilar can only resemble its reference product. Therefore, how biologics are named will directly impact clarity of information around which products a patient has been using. Greater clarity will obviously occur if biologics and biosimilars have distinguishable names, and that clarity will enable better safety monitoring, “adverse event” reporting and timeliness in managing adverse events if they occur, and can even help us better understand which products work better for certain patients and specific subpopulations.

Let’s employ some common sense here. Suppose parents were to give birth to a set of fraternal twins: would it make sense to name them both “Tim,” on the grounds that it would “level the competitive playing field” as they grow and master their fate? Or do the boys have the right — and the rest of world an interest — in being able to tell them apart? And while we’re on the subject of names, let’s remember that the name “biosimilar” was coined for a reason — as with fraternal twins, who are not identical. (Even if they were — and you wanted to marry one of them — you’d probably want your “choice” to be “informed” by their having distinguishable names.)

In the FTC’s eyes, it seems to come down to clarity of information versus eking out every possible cent of cost savings. It’s not worth the trade-off. Biosimilars have the potential to provide quality alternative medicines and to improve prices in the biologics space. Because of the complexities associated with all biologics (including biosimilars), however, cost savings from biosimilars are not expected to exceed 10 percent to 20 percent over branded products. Chemical compound generics can realize savings of up to 80 percent over brands.

If we go in the direction of non-unique names, and issues arise, we might not have the information we need to quickly understand which among similar products is causing the issue. That can unnecessarily affect trust across a class of drugs and biosimilars as a whole, and that could significantly affect uptake.

Biosimilars are already available in other parts of the world. This gives us a unique opportunity to learn from the experiences of those markets. In Europe, where biosimilars share the same names as the originator product, they’re experiencing an increased number of adverse events, and it can take months for manufacturers to determine if their product is causing the problem.

Thailand also uses nondistinguishable names and rapidly approved biosimilars to treat certain diseases, which has led to both a dramatic increase in the number of cases of life-threatening blood-related adverse events and near futility in efforts to track back to which products are causing the problems. Australia opted for distinguishable codes for all biologics, and they appear to be experiencing successful rollout and uptake of biosimilars.

It’s a universal reality: What’s in a name is a fundamental ability to tell things apart. Nothing more informs American competitiveness and informed consumer choice. No one more than the FTC should recognize that fact — and be its champion.

Peter J. Pitts, a former FDA associate commissioner, is president and co-founder of the Center for Medicine in the Public Interest.

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