By State Representative Sharon Cooper
(892 words)
Just as the new year brings exciting opportunities, as well as challenges, each new session of the Georgia General Assembly presents legislators with a myriad of issues that must be addressed. As Chairman of the House Health and Human Services Committee one such item my committee must deal with is the development of a set of guidelines for the use of a new group of innovative drugs that may soon be on the market.
Thousands of Georgians struggle daily with the debilitating effects of chronic diseases, such as arthritis, multiple sclerosis, lupus and cancer. Many of these life altering diseases can now be treated effectively with medicines known as biologics, whereas in the past more conventional medicines have been ineffective or inadequate at best. For example, many cancers known as melanomas are responding positively to a new biologic developed specifically for that disease. Before this new biologic became available, being diagnosed with a melanoma, unless caught very, very early, often came with a fatal prognosis.
Biologics are unique and highly complex drugs made from living organisms and today more and more are being developed to treat an even greater number of difficult and rare diseases.
No doubt this trend will continue, and for biologics already on the market, new alternatives known as biosimilars are about to become available to patients. This will expand patient treatment options at, hopefully, a reduced cost.
Biologics are not like other drugs, for they are not chemical compounds whose formulas can be duplicated exactly. Such duplications are what we call generic drugs. As I pointed out earlier, biologics are made from living cells, which interact with a patient’s own body cells. Therefore, their therapeutic effect can vary from patient to patient, not necessarily in a bad way, just differently, because every human being is different.
Biosimilars are so new that the FDA is just now reviewing the very first applications requesting they be approved for widespread use. That means the first biosimilars could be available in the U.S. later this year. Georgia law does not yet have usage guidelines in place should any of the four biosimilars up for approval receive a “gold star” approval designating them as interchangeable biosimilars. House Bill 195 and Senate Bill 51, both of which are sponsored by Senator Dean Burke, M.D., have been introduced to correct this omission.
The thing to remember about this new category of biologics is their name, biosimilars…similar, but not exactly the same. Simply put, this means that biosimilars are not generic versions of biologics. Think of a pair of twins, to the untrained eye, the twins may look exactly identical, but as you look closer at both of them, you will notice slight differences that make them unique, separate people. The same logic can be applied to biosimilars as they relate to biologics.
Given that biosimilars are not exact replicas of biologics, they cannot be substituted as a generic might be. Even with generics, patients sometimes say they don’t work as well as the original brand drug, even though the generic is an exact replica of the compound used to create the original drug. The difference could simply be that the compound used to hold the drug together is different and makes the patient react differently to the generic.
Since patients who require biologic therapies require more serious, complex and long-term medical management, there is a level of trust that builds between the patient and their healthcare team. The team develops a strong understanding of their patients’ medical history and their individual needs and problems. In order to guarantee that patients receive the best and safest care possible, strong lines of communication are essential between the patient and all members of the health care team. This is especially true since biosimilars will be ranked by the FDA into two categories. Substitution of regular biosimilars will not be allowed. However, biosimilars that have passed a higher standard of efficacy, which will be designated as interchangeable biosimilars, will be available for substitution. Even with interchangeable biosimilars, a patient can still respond differently than they did when taking the original biologic, so their physician must know when a substitution has occurred.
As a student nurse, the Catholic nuns that ran my school of nursing never let us forget that we were to put the needs of our patients first and that patient safety was a major priority. I have followed these principles throughout my career: first as a floor nurse, then as a nursing professor, and now as a legislator who chairs the House Health and Human Services Committee. Patient safety doesn’t have to be complicated. For example, hospitals now know that requiring staff to wash their hands between patients greatly reduces hospital infections. The key to patient safety when interchangeable biologics become available for substitution is simply good communication between the pharmacists dispensing the biologic and the patient’s physician. A simple phone call or electronic notification to the physician, along with letting the patient know if a substitution has been made, is all that it will take to ensure that these wonderful but highly complex drugs are safely made available to Georgia patients. As healthcare delivery becomes even more complex, involving the patient in all aspects of their care, along with better communication between their healthcare team members, can only lead to better patient satisfaction and healthcare outcomes.
Representative Sharon Cooper represents the citizens of District 43, which includes portions of Cobb County. She was elected into the House of Representatives in 1996, and currently serves as the Chairman of the Health & Human Services Committee. She also serves on the Judiciary Non- Civil, Regulated Industries, and Rules committees.
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