Dr. Michael Diaz Co-Authors ASCO Special Article That Helps Guide National Health Care Policy on Use of Biosimilars in Oncology

• Amanda Bridges
• March 16, 2018
• News

St. Petersburg, FL – March 15, 2018……Florida Cancer Specialists (FCS) Director of Patient Advocacy Dr. Michael Diaz, who practices at two FCS locations in St. Petersburg, co-authored a Special Health Care Policy article on biosimilar medications sanctioned by the American Society of Clinical Oncology (ASCO). Published February 2018 in the Journal of Clinical Oncology, the article contributes to national policy development on the use of biosimilars in oncology by offering information and guidance on biosimilars in the following areas: (1) naming, labeling, and other regulatory considerations, (2) safety and efficacy of biosimilars, (3) interchangeability, switching, and substitution, (4) value of biosimilars, and (5) prescriber and patient education.

Following several years of legal and regulatory battles, the development of biosimilars in the United States is now rapidly advancing, according to the National Institutes of Health (NIH). Biosimilars are not the same as generic medications; rather, they are biologic medicines that are similar to an already approved (reference) biologic. Their use in oncology is expected to play an important role in increasing access to new biologic medications and possibly lowering costs.

Like biologic medications, biosimilars are made from living cells, not chemicals. The living cells can cause minute differences in the different batches of the medicine each time it is made; therefore, the biologic medicine a patient takes will not be exactly the same every time. Both biologics and biosimilars go through extensive testing to ensure they will act in a similar way in the body. As stated in a February 2018 article in JAMA/Oncology, “Minor differences in clinically inactive components with no clinically meaningful differences between biosimilars and their reference biologic are allowed… A biosimilar has to have a similar route of administration, dosage, and strength as the reference biologic.”

As with all cancer drugs, the safety and efficacy of biosimilars are of supreme importance; however, empirical evidence is likely to play a larger role in the use of biosimilars. As Dr. Diaz’s article states, “Given that regulatory review of biosimilars, compared with reference products, relies less on clinical data and more on structural, functional, and pharmacologic data, there will be a greater reliance on postmarket evidence development to demonstrate the value of these products to stakeholders.”

Aspects of naming, labeling and other regulatory considerations of biologics are examined in this article, with a focus on oncologists understanding the significance of the name of each specific biosimilar, as well as the clinical information associated with the product. The issues of interchangeability and substitution are considered in the article as well, although, as of the publication date of this article, “…no biosimilar has been approved by the FDA as being interchangeable with its reference product.”

Dr. Diaz, who is Immediate Past President of the Florida Society of Clinical Oncology (FLASCO), said, “Interchangeability of each biosimilar is determined at the federal level by the FDA and decisions regarding substitutions at the state level. As a result, oncologists will have to work within local regulations and authorities as their treatment choices for patients might be affected. Will their patients be able to use the original reference product if their doctor prefers, or will they have to use its biosimilar? Depending on how many biosimilars there are for a reference product, this has the potential to become challenging for the ordering, administration and billing aspect for providers.”

Subsequently, the article contains a discussion of the value of biosimilars, including the elements of reimbursement, coverage and cost, and it advocates for a “…broad range of educational materials, sources, and formats… to be developed through a peer-review process, including appropriate conflict of interest provisions” that must be made available to all stakeholders. The article concludes with ASCO’s commitment to ensuring the availability of biologics and its pledge to continue educating oncology providers and advocating “… for federal and state policies that ensure the efficient approval, unrestricted access, and appropriate use of biosimilars.”

To access the complete article: http://ascopubs.org/doi/full/10.1200/JCO.2017.77.4893

SOURCES:
• JAMA Oncol. 2018 Feb 1;4(2):241-247. doi: 10.1001/jamaoncol.2017.2004 .
https://www.ncbi.nlm.nih.gov/pubmed/28727871

•OncLive.com
http://www.onclive.com/publications/oncology-live/2017/vol-18-no-09/oncology-pipeline-bursting-with-biosimilars

• FDA.gov http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

About Florida Cancer Specialists & Research Institute: (FLCancer.com)

Founded in 1984, Florida Cancer Specialists & Research Institute (FCS) is the largest independent medical oncology/hematology practice in the United States. With more than 220 physicians, 180 nurse practitioners and physician assistants and nearly 100 locations in our network, we are committed to providing world-class cancer care in community-based settings close to home.

Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. In the past 3 years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation.* Our physicians are consistently ranked nationally as Top Doctors by U.S. News & World Report. Trained in such prestigious medical schools and research institutes as Duke, Stanford, Harvard, Emory, M.D. Anderson, and Memorial Sloan-Kettering, the physicians of Florida Cancer Specialists provide leadership and consultation in the state’s leading hospitals.

FCS serves patients on the Gulf Coast from Naples to the greater Tampa Bay area, north as far as Tallahassee, in Orlando and surrounding Central Florida communities, and on the East Coast from Palm Beach County to the Jacksonville area.

Florida Cancer Specialists has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research and cutting-edge technologies that help advance targeted treatments and genetically-based immunotherapies, and embodied by our outstanding team of highly-trained and dedicated physicians, clinicians and staff.

* Prior to approval

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