South Florida Hospital News
Tuesday November 24, 2020
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October 2020 - Volume 17 - Issue 4
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Biosimilars: Moving Forward with New Cancer Treatment Options

Every year, more than 30,000 people in South Florida receive a dreaded cancer diagnosis. It’s a startling number and often causes families to worry about their loved ones, the cost of treatments, and the disruption to their lives and livelihoods. Thankfully, breakthroughs in oncology research and treatments continued to advance at a remarkable pace, benefiting patients and the health care professionals who work tirelessly to care for them.
 
But innovative treatments and new therapy options are only effective if people know about them – particularly the physicians striving to develop treatment plan for their cancer patients. As president of the Florida Society of Clinical Oncology (FLASCO) and a practicing physician, I recognize the tremendous benefit, for those of us who work in the oncology industry and for our patients, of communicating with one another about these new treatment options. This is particularly true if these options can improve patient care, minimize the impact on patients, or lower costs.
 
As one example, there is no doubt that the high cost associated with biologic cancer therapies – things like targeted therapy, immunotherapy, and hormonotherapy – has increased the overall cost of health care. At a time when increased patient access to affordable health care is so essential, it’s vitally important that the American health care system make greater use of what are known as “biosimilar” medications, which have been in limited use since they were introduced to the U.S. market five years ago.
 
Unlike generics, which are created through a chemical synthesis process, biosimilars come from living systems. But like generics, biosimilars can be produced more affordably than conventional treatment drugs. As their name suggests, these innovated treatments produce similar responses among the most sensitive patient population, and through a process of extrapolation they can be licensed for certain treatments that previously required traditional therapies – without the need for costly and time-consuming repeated clinical trials. This helps reduce development costs, which in turn ensures that biosimilars can be marketed at the lowest viable price and frees up resources to be allocated to other areas, such as research and development to help produce innovative new drugs.
 
There was a time when chemotherapy agents were the front line of cancer therapy. The high cost eventually led to the Hatch-Waxman Amendment in 1984, which encouraged the production of more affordable generics. More recent legislation, the Biologic Price Competition and Innovation Act of 2009, provided a way to license biosimilar agents, which are not chemically identical but are highly similar to an approved biologic agent.
 
There are many challenges in this wider use of biosimilars, beginning with the fact that physicians and other health providers are used to dealing with the more traditional approaches and don’t fully understand what biosimilars are. This creates mistrust and greater need for education among providers and patients. Another obstacle is the lack of inclusion in insurance formulary lists, which determine the treatments that are covered for patients. The reality is that biosimilars are developed through a rigorous process of scientific analysis and clinical studies to ensure their safety and effectiveness.
 
In 2019, the FDA finalized guidelines for manufacturers to follow in seeking approval of biosimilar interchangeability, so the innovative treatments can be used for a broader range of patients. Biosimilars are subject to the same official scrutiny as other medications, and since the first biosimilar was introduced in the American health care system in 2015, there is no evidence that any have been removed from the market due to concerns over effectiveness or safety.
 
At the beginning of 2020, before words like “coronavirus” or “pandemic” were part of everyday conversation, the federal government had approved 26 biosimilars, with more to come. If anything, the ongoing crisis has made affordable health care even more important.
 
As health care professionals, we have a responsibility to stay up to date on the latest developments in our fields. When learning about new treatment options like biosimilars, it’s important that we review the research and assess the benefits for our patients. If the treatment can end up reducing costs and increasing access for patients – especially those fighting cancer – then maybe we can start to minimize the prevalence and impact of devastating diseases on our communities.

Dr. Luis E. Raez is the President of the Florida Society of Clinical Oncology (FLASCO) and serves as the Chief Scientific Officer and Medical Director for Memorial Cancer Institute/Memorial Health Care System.

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