FDA must use caution with biosimilars

Those of us far removed from high school probably don’t think much about the fact that biology is very different than chemistry. It’s all just science to us, after all. But for people suffering from serious illnesses such as cancer or the threat of renal failure, the difference can be crucial when it comes to drugs that treat such diseases.

The Food and Drug Administration regulates the industry and assures us that a generic drug has the same active ingredients as the original formulation. The difference is that the original patent has expired, so other drug companies can manufacture generics, which generally save Americans considerable expense at the pharmacy.

Because of the ready acceptance of generic drugs that are chemically identical to the originals, it might be easy for us to assume that newer types of drugs have the same identical properties. We would be wrong.

Biologic drugs are developed and manufactured using living cells. The fastest growing segment of pharmacology, biologics include the cancer drug Avastin and the arthritis drug Enbrel. Because biologics are developed as three-dimensional molecules through proprietary processes, they cannot simply be copied as generic manufacturers copy drugs based on chemical properties. 

Change one of hundreds of complex combinations of sugars, proteins or acids in a biologic drug and you have something different. These drugs cannot be accurately reverse engineered.

Large generic drug manufacturers now have begun to create “biosimilars,” which are similar to biologics but not the same. The FDA now faces the challenge of how to test, approve and track the effectiveness and safety of biosimilars.

Following the directive of Congress to establish a pathway to approve biosimilars in the U.S. market, the FDA must balance the human desire to quickly bring new and less expensive treatments to market while protecting patient safety.

The FDA doesn’t need to start from scratch because regulatory agencies in the European Union, Canada, Japan and other countries already have established transparent pathways based on science rather than politics. (Unfortunately, some countries have significantly less-stringent controls for the sale of biosimilars.)

A successful pathway for biosimilars will require some basic building blocks:

• Because of the intrinsic differences in biosimilars drugs to the original biologics, the FDA must establish stringent clinical testing requirements for biosimilars. This cannot be a rubber-stamp process based on the original drug.

• We need to ensure that pharmacists, health care professionals and patients recognize the differences in biological and biosimilars drugs. Each should have unique names and barcodes, for example.

• The FDA needs to establish a stringent process for the continued tracking of the efficacy of biosimilars so that any adverse reactions or other events can be traced to the proper drug.

• Following the practice of Europe, Canada and others, do not allow pharmacies to substitute biologics with biosimilars without the express consent of a patient’s doctor. Given the science, two different manufacturers can never make identical biological products. The differences could have deadly consequences for patients.

Biology-based drugs hold the promise of great gains in the treatment of serious and complex illnesses and are predicted to represent more than half of all new drug approvals by 2015. The actions of the FDA today can have a significant impact on the success of these drugs and patient outcomes tomorrow.

William P. Bro is president of the Kidney Cancer Association (www.KidneyCancer.org).