Countless South Carolinians with chronic or life-threatening diseases such as arthritis, cancer, leukemia, multiple sclerosis, diabetes, epilepsy and HIV have been able to improve their quality of life or slow disease progression with innovative new medicines known as biologics.
Biologics are produced in living systems such as plant cells or microorganisms, and treat some of the most high-risk, critically ill patients. They are revolutionizing care of many diseases, but they also are very expensive, often costing thousands or tens of thousands of dollars a month. This puts them out of reach of many patients in our state.
Fortunately, the Food and Drug Administration has begun approving a new generation of equivalent biologic medicines called “biosimilars.” Biosimilars are “highly similar” to biologics, but since proteins made from living cells are impossible to replicate exactly, they are not identical. To be FDA approved, they must achieve the same clinical results as brand-name biologics. Four biosimilars have been approved since 2015, with dozens more in the pipeline.
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The increased treatment options that biosimilars will offer patients could lead to significant cost savings, just as generics cost less than brand-name drugs. I believe S.C. patients should have the opportunity to fully benefit from these cutting-edge medicines, so I have introduced H.3438, which lays the foundation to make biosimilars readily accessible to patients. My bill, along with a companion Senate bill, S.299, also will create a clear communication system for a patient’s health-care team.
My bill would allow pharmacists to substitute FDA-approved biosimilar treatments for the biologics if the patient agrees. Again, this is similar to a pharmacist substituting a generic for a brand-name drug.
S.C. law already has specific rules for safe generic substitution for conventional medicines; my bill would expand those rules to biosimilars.
The bill also sets up a communication system via electronic health records or another convenient means between the physician and pharmacist when biosimilar substitution occurs. This will result in a complete and accurate medical record, which is vital for monitoring outcomes and ensuring patient safety. And if physicians do not want a substitution to occur, they can stipulate that the prescription be dispensed as written, just as they can already do with generics.
Biosimilars truly are the future of medicine, and we must take steps now to prepare for this future. We have a responsibility to make sure our citizens living with chronic diseases have the greatest possible access to all medications, especially those that could represent significant cost savings.
Having access to game-changing biosimilars and a high level of communication among the health-care team is vital to battling disease and ensuring patients can live life to its fullest. The biosimilars bill would be a great victory for patients across South Carolina. In fact, Georgia, North Carolina and 24 other states already have passed laws to allow biosimilars substitution.
The time for South Carolina to act is now.
Rep. Henderson is a Greer businesswoman who chairs the health-care subcommittee of the House Legislative Oversight Committee; contact her at email@example.com.