The issue of substituting biosimilars has been widely misrepresented in the news media up to this point, and as the legislative chair of BioFlorida, the leading bioscience industry association in Florida, I feel I must weigh in on this critical issue.
Biologics are large, complex molecules that are created using living cells. Copies of biologics, also known as a biosimilars, are often described by the media to work the same way as the innovator product. While they are expected to produce the same outcomes, this simplifies a complex problem and summarily dismisses the need for patient safety provisions.
To clarify, biosimilars are only similar, not identical, to the innovator product, and they are only "expected" to produce the same clinical result as the biologic. And, when biosimilars are most commonly used to treat high-risk illnesses such as cancer, Crohn’s disease, rheumatoid arthritis and multiple sclerosis, we should leave little to chance when it comes to the health and safety of patients. Instituting safeguards to protect the patient will only serve to do just that and not prevent the substitution of biosimilars in any way. These safeguards aim to keep either the patient’s physician or treatment team in the loop in case adverse effects emerge so the source of the problems can be identified. This relationship and trust is vital for patient protection and health.
The proposed legislation that addresses biosimilar substitution in Florida doesn’t prevent the pharmacist from making a substitution, but only requires that they notify the patient of the choice to substitute, notify the prescribing physician of the substitution to an approved "interchangeable" biosimilar, follow "dispense as written" orders, and keep records of the substitution.
And, while the FDA is currently developing guidelines, they will only determine the regulatory process for the substitution of biosimilars, they will do nothing to address the dispensing of these medications, which is left to be decided upon by the states.
BioFlorida feels strongly that these provisions are necessary to ensure patient safety and do nothing to inhibit the dispensing of biosimilars. We are simply interested in protecting Florida’s patients and we’re proud that officials from our state are taking the initiative to protect our patients’ health and well-being, rather than waiting on the federal government to hand down rules and regulations.
Tom McLain, legislative chair, BioFlorida, West Palm Beach