By Francis B. Palumbo, Ph.D., Esq., executive director, University of Maryland School of Pharmacy, Center on Drugs and Public Policy - 09/21/09 10:51 PM EDT
These are injected biologicals used to treat many truly dreaded diseases such as cancer and multiple sclerosis, as well as other serious illnesses. They are made from organic sources such as animal cells, microorganisms and yeast, and have given new hope and new life to many people with crippling illness.
Even though for the first time in recent history overall expenditures for drugs increased at a lower rate than for healthcare in general, expenditures nevertheless did increase, especially for biosimilars. Patients (or their payers) can spend thousands of dollars per month for some of these biologicals, and overall, expenditures for these life-saving products can top $40 billion annually.
Generic drugs approved under what is known as the ANDA (abbreviated new drug application) are able to take advantage of the Hatch-Waxman Act passed in 1984. This act created a scientifically-based scheme for approval of generic drugs once the patent on the brand or innovator has expired. Patients have come to rely on generic copies of brand-name small molecule drugs to cure their illnesses and maintain their lives. Unfortunately, Hatch-Waxman made no provision for biologicals and almost all of the large molecules for serious illness are biologicals.
Congress is trying to remedy this, but the science is not the same. Simply put, “generic” biologicals may not be an exact copy of the originator brand-name product. So recognizing this, the proposed legislation seeks to give the Food and Drug Administration discretion to determine whether a biosimilar is close enough for all intents and purposes to be considered a substitute for the originator brand-name product.
In this present-day environment, it would be unrealistic to fail to support any reasonable measure to make medicines more affordable. Congress should grant FDA the authority to require both safety and efficacy testing where needed, on a case-by-case basis. There should also be well spelled-out and publicly reviewed criteria for FDA to use in making this determination. And, one biosimilar should not be substituted for another without the express permission of the prescriber. This is science, not policy. It is in the interest of good patient care, and is certainly in keeping with the need for evidence-based medicine.
College Park, Md.