12/14/2010 08:07 am ET Updated May 25, 2011

Biologic Drugs: Biosimilars May Be Cheaper, But Are They Safe?

Where there's medicine, there's money.

That statement should come as no surprise to anyone who has ever looked at a medical bill or filled a prescription: Pharmaceuticals alone are a more than $800-billion market ($300 billion of that is in the United States alone).

But the statement has an important corollary: where there's money, there will always be people seeking to influence the rules for how that money can be made, and by whom.

There's not necessarily anything wrong with that; after all, making money is the American way and everyone wants to protect their piece of the pie. But when it comes to medicine, patients deserve to know how decisions being made at high levels -- by governments and corporations -- will affect their access to needed medications.

Last week, the European Medicines Agency -- the equivalent of a European FDA -- decided, but has not yet released, new guidelines for how pharmaceutical companies can develop copycat versions of a type of drug called biologics. The rules apply to Europe, but will likely influence the approach taken in other countries, including the United States.

Unlike traditional pharmaceuticals made from chemicals, like Lipitor or Prozac, biologics originate from living organisms. Biologics are comparatively new, and until recently, patent protections limited opportunities for developing copycat versions. But expiring patents and new legislation are opening opportunities for drug makers to develop copycat versions of biologics that will eventually be available to patients in the Unites State, Europe and elsewhere.

Some may argue that copycat versions of biologics will be cheaper. The biosimilar companies won't have had to spend as much money on research or clinical trials, and thus won't have as many costs to recoup as the original drug maker, who had to prove the biologic actually works, and is safe -- a rigorous process that can cost hundreds of millions of dollars.

But there's another important question lurking beneath the surface. Will patient safety be sacrificed to give copycat drug companies the right to make biosimilars? Unlike chemically based pharmaceuticals, of which an exact copy can be made, it's not possible to create an identical version of a biologic. Just as no two living things are alike, even the best "twin" will still be a little different. That's why for biologics, there's no such thing as a "generic" -- biosimilar is as close as you get. As a result, drug companies can't prove that the biosimilar is equally as safe as the original biologic due to the complicated science that goes into making biologics.

All of this leaves policymakers like the EMA and FDA with a tricky question: How similar is similar enough to be proven safe? Understandably, drug safety agencies can't mandate that biosimilars are identical, because it's impossible. What they can require, and the EMA should, is that the biosimilar drug makers be held to identically high standards for proving that the drugs actually work, and are equally safe.

If this seems like an obvious point, remember where there's medicine, there's money, and those seeking to influence the drug approval process to their benefit. Some drug makers argue that as long as the biosimilar can be sold more cheaply than the original biologic, there is an "acceptable (level of) risk" that some patients may find that the copycat drug doesn't work as well as the original, or has unforeseen side effects. The unfortunate flaw in this argument is simply, what is an acceptable risk -- a patient's life? What is safe and/or effective for one patient may or may not be for another; the way to know for sure is to require clinical trials.

To paraphrase Aldous Huxley, biologics are a brave, exciting new world of medicine. But the EMA's new guidelines should put patient safety first by requiring biosimilars to be held to the same safety and efficacy standards as the original drug.