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New Drug Therapies Need New Thinking on Regulation
 
By Thair Phillips
 
 The biotech revolution has brought hope to millions of Americans coping with some of the most devastating medical conditions, including cancer, Parkinson ’s disease, and rheumatoid arthritis. New prescription drugs, known as biologics, that were born of this revolution now comprise the fastest growing segment of the pharmaceutical market and could account for half of all new drugs approved by 2015.
 
 With intense pressure on governments to control rising health care costs, a push is underway to introduce lower-cost biotech medicines that function more or less as equivalents of these biologics. But a host of complicating factors surrounding biologics—not least of which is patient safety—have doctors, patients, drug companies, and regulators trying to work through the thorny problems unique to these drugs.
 
I don’t use the term “generics” for these follow-on biologics for good reason. That’s because there is no easy way to “knock off” a biologic drug and the reason for that is hidden in the chemistry. Biologics, because they are produced with unique and proprietary processes involving living cells, are characterized by long, complex molecular structures. You don’t need to learn the chemistry but it’s helpful to understand that these long, complex molecules differ radically from the “small molecule” structure of a typical drug that is synthesized in a chemical process. As a result, no two biologic drugs made from different cell lines or different processes will be identical. Small differences can also have unexpected or harmful clinical outcomes.
 
That’s why the term biosimilar is preferred when used to distinguish the follow-on drug from the original biologic. Currently, the Food and Drug Administration is studying how to craft a formal process to approve biosimilars that takes into account the technology involved, respects cost issues, and preserves patient safety.
 
How do we get this right? First, it is critical that a science-based approach be used to establish a regulatory pathway to market for biosimilars. The United States should follow the first formal pathway developed in 2003 by the European Union and improve on it.  The EU now has a lot of scientific data which can, in both a positive and negative sense, inform our own policy makers as they move forward.
 
In tandem with this, we need to put in place policies that will detect, assess, understand, and prevent adverse effects, including both long-term and short-term side effects. Here again, the biosimilar requires, unlike the typical “generic” prescription drug, monitoring for possible adverse effects. That means clinical trials before release to market and mechanisms that will allow traceability once approved. The best way to trace a biosimilar will be to require the use of unique names rather than “family names” as is often the practice with generic prescription drugs today.
 
Most of all, we need to keep doctors and patients in the loop. They should be the ones making the important decisions on treatments—not legislators and regulators. That’s important to keep in view as the biosimilar regulatory path is being developed. Rules should be put in place that ensure that treatments may not be altered by a pharmacist or others without the consent of the treating physician and the patient.
 
New biotech-based therapies hold tremendous potential for millions of patients who, until recently, had little hope of finding effective treatments. Yet, as new biosimilars move to market, we can’t lose sight of the fact that patient safety must not be compromised.
 
Thair Phillips is the President of RetireSafe, a nonprofit grassroots advocacy organization representing more than 400,000 older Americans nationwide. For more information go to: www.retiresafe.org 
 
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Sources/background:
 
The Alliance for Safe Biologic Medicines
 
Resources for You (Biologics)
 
Overlooked but Not Forgotten: Three Lesser-Known Reforms
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