Four things you should know about the next wave of treatment for chronic diseases—biosimilars
To clarify some of the details surrounding the abbreviated licensure pathway for biosimilars, Healio spoke with Leah Christl, PhD, associate director for therapeutic biologics, FDA
The proliferation and success of biotherapeutics for a variety of autoimmune, autoinflammatory and related conditions have come at a massive societal cost in terms of money
An abbreviated licensure pathway was developed for biologics that are “biosimilar” to FDA-approved reference products, reducing costs and expanding patient access to these therapies
Biosimilars are here, and physicians should arm themselves with knowledge to better prepare themselves and their patients for the future
The goal of biosimilar development is to spur competition in the biologics market and thereby reduce costs to the health care system and expand patient access to biological therapies
As more biosimilars are approved by the FDA, and with more in the development pipeline, the issue of interchangeability is causing concern among physicians about the future of biosimilars
“If we want things to stay as they are, things will have to change.”
I have used this quote often when I have discussed iterative change in the fields of rheumatology and immunology, but there is no other area where this iconic statement is more relative than in the discussion of biosimilars.
First, a digression: The quote itself is from the iconic book of life and change in Sicily in the 19th century, The Leopard (Italian: Il Gattopardo) by Giuseppe Tomasi di Lampedusa. The book itself was criticized by everyone, but later considered a masterwork and acclaimed by the masses. So, what does this have to do with biosimilars?
We live in a most exciting era of biotechnological advances and for two decades have had the privilege to witness the proliferation and success of biotherapeutics for a variety of autoimmune, autoinflammatory and related conditions. On the plus side, they have been transformational for patients; on the minus side, they have introduced some formidable and exotic toxicities that we have learned to manage. Importantly — and this cannot be minimized — they have come at a massive societal cost in terms of money.
Physicians in the field need no refresher on the monetary costs of biologics to our patients, for we hear from them all the time. They often cost $50,000 or more per year, and from the lucky with excellent insurance, we hear little complaint as they benefit from their use. From the unlucky without access, we hear little for they have yet to experience any benefit. Increasingly, however, we are witnessing the creep of co-pays that can exceed several thousands of dollars per year, a large sum for almost anyone, especially those on fixed incomes. Furthermore, some of our biotherapeutics have been around for two decades and in that time have essentially doubled in price (well, after the massive initial investment for their approval); for me this is hard to swallow. Globally this market is approximately $250 billion yearly and is on trajectory for significant growth, which is unsustainable given the competition for health dollars. Thus, enter biosimilars.
I will not discuss the scientific aspects or even the clinical aspects of these agents, as this resource center has plenty of granular information on areas such as production, equivalency, extrapolation, immunogenicity and interchangeability (so read on!). I will now only reflect on costs. The United States has the dubious distinction of being a country where we allow and absorb 2,000% to 5,000% mark-ups for generic drugs like colchicine and pyrimethamine. Putting aside our world leading status in paying for medicine in general, we should again look to Europe for what could be possible. In Norway where biosimilar infliximab (Inflectra, Celltrion) was introduced in 2013, the competitive price has whittled down to over a 50% cost savings over just 3 years. Notwithstanding the influence of other drugs (there are many others on the way) do the math on what this could mean to patient care. It has been projected that biosimilars could save the health care industry a quarter of a trillion dollars over the next decade. Now that’s money!
The Charter on Medical Professionalism in the New Millennium (Ann Intern Med. 2002;136:243-246) has been part of our professional landscape since 2002. I like to refer to it as the 95% confidence interval for our professional aspirations. It is literally endorsed by scores of national and international organizations, including the American Board of Internal Medicine, the American College of Physicians and many other groups. The document, which I teach in our medical school but unfortunately has been read by relatively few physicians, asserts three Principles and 10 Commitments. I will point out one of each that have implications for the field of biosimilars.
Principle of social justice
The medical profession must promote justice in the health care system, including the fair distribution of health care resources. Physicians should work actively to eliminate discrimination in health care, whether based on race, sex, socioeconomic status, ethnicity, religion or any other social category.
Commitment to a just distribution of finite resources
While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost effective care.
These two statements should give us some pause as we now consider the potential of biosimilars throughout the practice of medicine.
If we can answer the critical issues on safety and efficacy of biosimilars — and we do seem to truly be headed in that direction — then think about biosimilars as a decision about professionalism, social justice and resource allocation. Am I dreaming about what a cost savings of 50% could mean in the U.S. and throughout the world? We all want biologic therapeutics to be options for our patients, regardless of their ability to afford and pay. If this is going to happen then things must change. Biosimilars are now front and center — stay tuned.
For more information:
Leonard H. Calabrese, DO, is chief medical editor of Healio Rheumatology and vice chair of rheumatic and immunologic disease at Cleveland Clinic.
Disclosure: Calabrese reports he is a consultant for AbbVie, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen, Pfizer and Sanofi; and is on the speakers bureau for AbbVie, Bristol-Myers Squibb, Crescendo Bioscience and Genentech.
Biosimilars: Why now? Why not?
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