By Bruce Feinberg, D.O., Cardinal Health Specialty Solutions
In the past two years, nine biosimilars have been approved by the FDA, three for use in cancer patients and six for use in patients with inflammatory arthritis and inflammatory bowel diseases.
Despite the fact that many practitioners have never prescribed a biosimilar, awareness of this emerging drug class is strong and growing. According to a 2017 survey of 200 community oncologists conducted by Cardinal Health Specialty Solutions, only 17 percent of participating physicians said they were unfamiliar with biosimilars. This is an improvement from the year prior, when 22 percent indicated lack of familiarity.
A number of factors are likely leading to this growing awareness. In the past several years, we’ve seen a myriad of published literature confirming the efficacy of biosimilars. And as more products have earned FDA approval, we’ve seen increased dialogue about biosimilars at medical congresses and international meetings.
In addition to growing awareness, the survey found wide acceptance of the FDA’s process for evaluating biosimilars. Almost 80 percent of participating physicians stated they were comfortable with the approval process for biosimilars, while only five percent said they thought the FDA was rushing biosimilars through the process.
Also encouraging, a strong majority of oncologists surveyed indicated a willingness to prescribe biosimilars across all reference brand label indications and therapeutic areas, regardless of whether the biosimilar is supportive care or therapeutic or whether it is a palliative treatment or used with curative intent. Such responses suggest the barriers to biosimilar adoption are much lower now than they were a year or two ago.
Despite these trends, biosimilars still face real barriers to adoption. Randomized clinical trials of biosimilars are limited to one indication and designed only to prove non-inferiority. Label expansion to all reference brand indications is made by extrapolation. And the FDA has not yet classified any biosimilars as being interchangeable with reference brands, as generic drugs are. Despite growing physician awareness of and willingness to prescribe biosimilars, these factors may lead to reluctance to prescribe, once the question moves from theoretical to the point of care.
That said, biosimilar developers can take several key actions to bridge the gap between awareness and action in 2018 and beyond.
When it comes to defining cost structures, biosimilar developers should reach out early to payers, both government and commercial, as well as providers and other stakeholders, to clearly articulate how their products can promote cost efficiency and sustainability within the healthcare system. Gaining consensus on the cost structure may be challenging because each stakeholder will expect to benefit, and providers and patients may be slower to adopt biosimilars if they perceive that all of the savings go to payers.
Industry experts seem to agree that an uptick in biosimilar adoption is likely in 2018. The question now is: at what speed and scope will the change in prescribing patterns take place?
History tells us changes in physician attitudes and awareness don’t always correlate to a change in behavior at the point of care. And biosimilars also need to overcome clinical hurdles to provider acceptance — hurdles reference brands and generics don’t face. That makes it all the more important for biosimilar developers to focus on collaborating with key stakeholders to create a compelling value equation. It also means commercialization plans, provider education, and patient support services must be best-in-class if biosimilar developers truly aim to transform awareness into prescribing action.
About The Author:
Bruce Feinberg, D.O., is VP of clinical affairs and chief medical officer for Cardinal Health Specialty Solutions, where he serves as a consultant with payers, providers, pharma, patients, and policy makers.
Prior to joining Cardinal Health, Dr. Feinberg was the founder and CEO of Georgia Cancer Specialists (GCS), one of the largest integrated oncology specialty practices in the U.S. At GCS, he pioneered health information technology, clinical pathways, and the oncology medical home.
Dr. Feinberg has made more than 70 peer-reviewed contributions to the value-based healthcare literature. He is the author of the bestselling book Breast Cancer Answers: Understanding And Fighting Breast Cancer and hosts The Weekly Check-Up on WSB Radio in Atlanta.