Patient Safety with Biosimilars: Not the Same, Only Similar


Scientific advancements in medicine are important achievements that improve quality of life for many people.  One recent example is in the field of biotech medicines.  But in the rush to make generic versions of these drugs, patient safety could be compromised. 

Biologics are advanced prescription drugs that harness the power of living organisms to treat debilitating diseases like cancer and arthritis.  These types of drugs are expected to account for half of the new drugs approved in the next few years, as biologics constitute the fastest-growing division of the pharmaceutical market.  And for good reason: Biotech medicine promises to be our best bet for treating the most devastating serious illnesses for which there are currently no effective treatments. 

Biologics are manufactured through a distinctive, proprietary process involving living cells.  Because they are engineered differently than the more common chemical-made small-molecule drugs, biologics are highly complex compounds that are very sensitive to the manufacturing process.  Altering a single cell or part of the process can change the entire drug or the effect it has on the body, and currently, science cannot detect all of the differences between molecules. 

Because the process of manufacturing biologics is so sensitive and complex, and because the resulting compounds are made from living organisms, no generic versions of these drugs exist in the U.S. market.  Recently, however, new legislation accelerated the process of creating the first generic copies of biologics, known as biosimilars. 

As their name suggests, biosimilars are similar to—but not exact copies of—biologics.  Unlike generic medications, biosimilars do not use the same raw materials or production process as the original biologics.  And since biologics are, by nature, complex compounds, anything less than exact copies of these biotech medicines could be dangerous to the human body and unpredictable against disease.  Certainly it is cost effective to produce generic versions of biologics, but our desire for lower drug prices must be balanced with patient safety. 

It is important to develop a pathway for biosimilars to enter the market, but before this can happen, a vigilant traceability system must be in place to protect patients.  Necessary measures like required clinical trials, transparent product labels, and a system to report adverse reactions must be established first.  The system currently in place is inadequate and was not designed to be used with multi-source biologics. 

But more fundamentally, it is paramount that the standard for designating whether drugs are truly interchangeable remains high.  As history indicates, once the FDA determines a product to be interchangeable, patients are frequently switched between a wide range of products.  The problematic result of doing this with biosimilars is that any adverse reactions become nearly impossible to trace to the correct manufacturer—which is critical for ensuring the safe use of biotech medicines. 

And all else aside, it is imperative that doctors and their patients make health care decisions together.  The decision of which available treatment is best should be left to them, not to regulators, insurers, or legislators.  Any part of the approval process for biosimilars must reinforce this crucial idea, because switching biologics for biosimilars without the consent of the patient or doctor could pose serious risks to patient safety and health.

If patient care is compromised, it doesn’t much matter what medical miracles these drugs might be capable of producing.  We all want to have access to effective, innovative drugs at lower prices, but we must make sure that the pathway to biosimilars is responsible, science-based, and governed by patient safety. 

Bruce S. Rubin, MD, is an Assistant Professor of Clinical Neurology at the University of Miami Miller School of Medicine. 


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