03/31/2011 08:25 am ET | Updated May 31, 2011

Biosimilar and Counterfeit Meds: When Do They Become Dangerous?

A recent 60 Minutes special blasted open the dark and dangerous world of counterfeit drugs -- a multi-billion dollar market that potentially affects the health and safety of anybody taking a prescription drug. The tens of thousands of fake prescription drugs that enter the U.S. each year range from sugar pills that fail to deliver necessary medical benefits, to those containing actual toxins that can kill (and indeed, have been linked to fatalities).

Over the last few decades, regulators and private industry, working together, have improved their collective sense of what works and what doesn't, to fight counterfeiters. What if they were able to go back in time and apply these "lessons learned" decades ago, saving countless lives?

They can't, of course -- but there is an opportunity to apply that collective wisdom to a class of relatively new drugs called "biologics." Precisely because biologics, which are made from living organisms, show significant promise, they will inevitably be a target for counterfeiters intent on making outrageous profits at the expense of patient safety.

So what can be done to prevent prescription drug counterfeiters from injecting the U.S. market with fake biologics?

First, the FDA is currently considering what is called an "abbreviated pathway" for approving legal knock-offs of biologics (called "biosimilars") that will enable copycat and thus cheaper versions of these life-saving medications to become FDA-approved. It's important to ensure that this process doesn't cut corners: the FDA should hold biosimilars to the same standards of safety as the original biologics. Unlike non-biologic medicines, where a "generic" version is more or less an exact chemical replica, biosimilars can never truly be identical to the original biologic. Hence, the only way to ensure the same level of safety is to require similarly rigorous clinical testing for biosimilars as is required for the original biologics.

Second, it's important to be open-eyed about how counterfeiters operate. Some have been known to insert convincingly real-looking counterfeits into the normal prescription drug supply chain. "Track and trace" technology affords regulators and drug companies the ability to follow a drug's supply chain back to the origin.

Third, it's important to empower pharmacists, physicians and patients. When a biosimilar is approved, labels and product names should adequately educate the reader as to whether the drug is the original biologic or a copycat biosimilar. As with any product, it's tempting for copycat manufacturers to want to cash in on the original creator's trademark, suggesting that the products are identical; but when it comes to medicines, is it safe to allow that?