This section called “CME Corner,” highlights, when available, relevant continuing medical education (CME) opportunities deemed to be of use to readers. Articles include an overview of a specific area where key opinion leaders have determined there to be an educational need and a link to the available CME program.
The CME program titled "Biosimilars and Oncology Clinical Pathways: Perfect Together" is currently available on this topic until December 10, 2020.
From 2015 to 2019, 26 biosimilars were approved by the Food and Drug Administration (FDA) for use in medical care in the United States, the majority of which have relevance to oncology. Specifically, over the course of 2019, the FDA approved 6 biosimilars that are relevant to oncology.1 Biosimilars are highly similar to their respective original biologic products and are safe and efficacious.2 These newer products provide an alternative to the originators, increasing competition in the market for the purpose of reducing costs and improving access.
The most compelling reason to incorporate biosimilars into clinical pathways is certainly the same reason for incorporating biosimilars into other avenues of systematic clinical care, like guidelines and CME programs: to make sure that providers are aware of the availability of these agents, as it is a rapidly changing field.
The approved biosimilars have been studied very carefully, not only by the FDA during their regulatory process—which is a rigorous and reasonably efficient process to protect safety and indicate the efficacy of these agents for approved indications—but also by the professional community, who reviews evidence and published literature prior to integration into guidelines and pathways.
The ultimate test will be whether the anticancer biosimilars such as trastuzumab, rituximab, and bevacizumab actually offer a meaningful price reduction to their expensive originator biologic therapies. Lower prices via more competition would not only help reign in health care expenditures but also improve access for patients with less financial means.
Uptake in the US Market
The supportive care biosimilars that have been FDA approved between 2017 and 2019 have largely been embraced.3 More than half of the use of filgrastim in the United States belongs to biosimilar filgrastim rather than the originator.4 There has been fairly rapid uptake of supportive care biosimilars into practice, and we have also seen an early reduction in pricing for these products.5
We hope that, as competition continues to increase, the 10% to 12% price reduction noted with early data5 becomes closer to 20% or 30%. The price reduction rate will never be 80% like with generics because the latter can be synthesized exactly the same as originators in a laboratory, but there will be a basement effect price reduction, below which it is no longer profitable to make a biosimilar. Nonetheless, a 20% or 30% reduction of a multibillion dollar worldwide industry is a substantial amount of savings for the health care system.
My belief is that we will see a gradual and differential uptake in anticancer biosimilars, perhaps beginning in patients who are being treated in a palliative setting—not necessarily for cure but rather for disease control. Eventually, as provider confidence grows and the data continues to show that anticancer biosimilars are efficacious and safe, these agents will move into more common use in the early-stage curative setting.
Interchangeability Designations
The concept and the definition of interchangeability is unique to the US FDA. It is not a criterion or a category that biosimilars or any other drugs are put into in Europe or other parts of the world. The FDA provides a formal definition of interchangeability, for which they have promulgated rules and regulatory requirements, including the need for additional clinical trial data and demonstration that you can switch back and forth between originator and biosimilar or between biosimilars.2 Presently, no biosimilar has been granted interchangeability designation in a formal sense. To my knowledge, no company has formally requested this designation, but this information is not necessarily in the public domain.
In the future, there may be some desire and attempt to gain an interchangeability designation. The challenge for industry is procuring additional clinical trial data, which is required for this designation and increases costs considerably. The price tag for trying to achieve this designation is significant to say the least. On the other hand, a company may conclude in the future that such a designation may offer them an advantage in a competitive market. Complicating the issue of interchangeability designation is that, in a certain sense, switching is already happening in the real world. There are multiple agents for a given indication, and there may be a preferred agent based on payers’ terms of reimbursement or by providers in terms of contract agreements.
The United States has a very mobile population, and when cancer patients, for instance, move south for the winter months and continue to receive cancer treatment, they may be treated at an institution or practice that uses a different preferred biosimilar. We know this to be happening, but there has been minimal attention to this issue. In this sense, interchangeable use of these agents is already taking place, and guidelines permit use of any agents once they are FDA approved for the designation of biosimilarity. All indications today, though not systematically evaluated, are that these drugs are interchangeable without any issues with safety or loss of efficacy.
Biosimilar Entry Into Guidelines and Pathways
At the end of the day, all final decisions regarding biosimilar use is going to be made at a local level. That is, institutions and payers will have the most say over whether these agents are to be utilized based on their prescribing and coverage decisions.
The good news for biosimilars that have been FDA approved is that they have already started to be incorporated as equal options to originators in clinical guidelines from the American Society of Clinical Oncology6 and the National Comprehensive Cancer Network.7 We are seeing biosimilars being further embraced and utilized in clinical practice through incorporation into pathways. Specifically, some of the provider pathways that I am familiar with are already embracing biosimilars. It seems that some institutions have decided, after looking at the evidence, that biosimilars are equally effective and as safe as their originator but with the added bonus of potentially saving health care dollars.
The primary goal of pathways is to improve the quality and consistency of care as well as clinical outcomes, but part of the pathway design involves reigning in costs. The idea is to use agents that are as good, if not better, than those that have been used traditionally but at a reasonable or sometimes lower cost. If an agent is just as efficacious but offered at a lower cost to the patient, it truly is a win for the patient and for the health care system.
The CME program titled "Biosimilars and Oncology Clinical Pathways: Perfect Together" is currently available on this topic until December 10, 2020.
References
1. Food and Drug Administration (FDA). Biosimilar product information. fda.gov website. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Updated November 15, 2019. Accessed February 13, 2020.
2. Food and Drug Administration (FDA). Biosimilar and interchangeable products. fda.gov website. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Updated October 23, 2017. Accessed February 13, 2020.
3. Becker PS, Griffiths EA, Alwan LM, et al. NCCN Guidelines insights: hematopoietic growth factors, version 1.2020. J Natl Compr Canc Netw. 2020;18(1):12-22. doi:10.6004/jnccn.2020.0002
4. Kozlowski S, Birger N, Bereton S, et al. Uptake of the biologic filgrastim and its biosimilar product among the Medicare population. JAMA. 2018;320(9):929-931. doi:10.1001/jama.2018.9014
5. Chen X, Agiro A, Barron J, Debono D, Fisch M. Early adoption of biosimilar growth factors in supportive care. JAMA Oncol. 2018;4(12):1779-1781. doi:10.1001/jamaoncol.2018.5090
6. Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36(12):1260-1265. doi:10.1200/JCO.2017.77.4893
7. Zelenetz AD, Ahmed I, Braud EL, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9(suppl 4):1-26. doi:10.6004/jnccn.2011.0136
