ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel:
The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be treated? How will the disease progress? What are the health care options? Thanks to breakthroughs in the field of biotechnology, we are now able to offer them hope. Biotechnology has changed the game for neurologists. Several biologic medicines have been developed to reduce relapses of MS and slow down damage to the central nervous system, caused by the disease’s progression. Biologics are cutting-edge because they are manufactured with living cells, and they are able to specifically target the immune system in ways that chemical drugs cannot. Besides MS, biologics are also used to treat cancer, Parkinson’s disease, rheumatoid arthritis and autoimmune diseases.
In the laboratory, scientists manipulate living cells to grow these large, complex, genetically engineered molecules. A finished biologic product is thousands of times larger than a chemical drug like Ibuprofen. The complicated structure of these medicines makes them more susceptible to environmentalchanges and requires cautious handling by medical professionals.
To ensure safety of the patients taking biologic medicines, I lend my support, as a neurologist, to legislation working its way through the Florida Legislature, which will safely allow for the substitution of a new category of imitative biologic medicines, known as biosimilars.
House Bill 365 and Senate Bill 732 would help keep doctors aware of any substitutions made by pharmacists for interchangeable biosimilars. Physician notification is necessary to the success of my practice. Because of the unique characteristics of biologics and biosimilars, it is extremely important for me to know if a change had been made in my prescription. If a patient has an adverse reaction to a medicine, I would need to be able to identify the specific product that the patient received.
These bills provide the necessary safeguards to make biosimilars accessible for the residents of Florida and give specialists like myself the assurances they need to prescribe biologics at pharmacy counters.
Dr. Bruce S. Rubin is a board certified neurologist, voluntary assistant professor of Clinical Neurology at the University Of Miami Miller School of Medicine and director of the Spasticity Clinic at Jackson Memorial Hospital.