In September 2015 the first biosimilar Zarxio, the alternative to Neupogen, was made available to US patients. Since then, as a lower-cost treatment option, biosimilars have been touted as a partial solution to the increasing costs associated with the US healthcare system. Now, the role of biosimilars is more important than ever as deferred care from Covid-19 is likely to increase annual costs in the US somewhere between $30 billion and $65 billion.

In 2019, the US biosimilar market was worth $737.2 million and continues to grow with a CAGR of 46.2% forecast for 2020-2027, however many are frustrated at the current rate of adoption in the US. But with increasing healthcare costs and a growing debt from Covid-19, what does the next year hold for biosimilar adoption across the US?


Where we are now…

Following the success of biosimilars in Europe, the US has struggled to shadow. As of March 2021, the US Food and Drug Administration has approved 29 biosimilars, however, not all of these are commercially available largely due to patent litigation. I spoke to a senior commercial leader within the pharmaceutical industry who said “the US healthcare system and contracting for medicines to be covered in the US functions, is a different healthcare system to that of Europe. This has been shown repeatedly where lower-cost alternatives are not covered compared to higher-priced alternatives that provide rebates for pharmacy staff and better reimbursement for physicians.” The difference in healthcare systems between the US and Europe as well as a broader set of barriers has led to a lower-than-expected adoption of biosimilars across the US. Various challenges and barriers exist including the lengthy timeline of production and approval of biosimilars and issues with adoption due to patients’ safety concerns and pharmacists concerns regarding laws and regulations. However, the rise of biosimilars within Europe is evident, and this is due to the benefits they bring not only to the public, but also to pharmacists and the healthcare system in general. Uptake increases with time and Europe is several years ahead of the US.  


What will 2021 hold for biosimilars in the US?

The seventh edition of Amgen’s annual Biosimilar Trends Report highlighted major growth within the biosimilar market in the US. The report highlights a 65% increase in biosimilar approvals and a 157% increase in the number of available biosimilars in 2019, which will continue to aid in cost savings for the US healthcare system. An IQVIA study has suggested that biosimilars are already on track to reduce healthcare costs by $100 billion over the next five years with 108 biosimilars in development across 22 molecules potentially reaching the US market in the next 10 years. One of the senior commercial leaders I spoke to said, “In 2021 we can expect to see an increase in market penetration and price erosion. Adoption starts to happen when you have multiple products entering and we are already starting to see that.”

In 2020, the FDA added around 90 additional molecules from the traditional drug approval pathway to the biologic drug approval category and this will hopefully lead to newer classes of medicines coming in. A senior commercial leader I interviewed commented, “Traditionally we have seen the anti-inflammatory, oncology supportive care products that came first, now we will see a slow line of products coming out including insulin medicines and treatments for MS.” Prices have soared for some treatments due to the lack of competition and the creation of new biosimilars has the potential to offer real cost savings for a healthcare system shaken by Covid. With an increasing number of biosimilar approvals and a strong pipeline of products from several companies, the IQVIA Institute estimates that competition in the global biosimilar market will be nearly three times greater in 2023 than it is now and with the increasing healthcare costs hopefully this will be something we see in the US. In a recent interview, Sean McGowan – Senior Director of Biosimilars for the wholesaler AmerisourceBergen – stated, “Covid-19’s impact on the healthcare system may help accelerate the utilization and growth of biosimilars in the United States. As the government continues to look for ways to lower healthcare costs and reduce out-of-pocket expenses for patients, we may see quicker adoption of legislation that supports the biosimilar category. In turn, biosimilars could emerge as a preferred choice for payers, physicians, and patients due to the potential cost saving and expanded access benefits they offer.” Whilst the future looks promising there are still many barriers that need to be overcome.

One of the biggest barriers for adoption amongst those who I interviewed for this article was rebate contracting and some believe the market is not competing on price but on rebate. One senior leader said, “primarily we have seen issues related to contracting and rebate contracting. The rebate wall has prohibited the use of biosimilars or discouraged the use of biosimilars in the marketplace, down to the insurers and the pharmacy benefit managers that exist in the US market. We have crossed that barrier some-what with the newer class, especially in the oncology space, but what we’re running into is resistance by providers to take on and utilize biosimilars in the market.” He told me, “I have multiple examples of biosimilars in the US where there is lack of uptake because of rebate contracting and lower-cost alternatives or authorised generics are not being utilized because of rebate contracting. Without intervention from policymarkers it is my view that we are going to be in this constant swirl of drug pricing issues, but alternatively if policymakers are pushed to fix this and start prohibiting rebate contracting we will get price controls in the US.” There are conflicting views and opinions across the pharmaceutical industry on whether intervention is indeed needed and with a new administration in the US we will have to wait and see if this is a step policymakers will take.

In addition, many patients and physicians are unaware of biosimilars or are concerned about their safety and efficacy. As of 2018, research by PwC’s Health Research Institute showed 55% of clinicians surveyed said they were unfamiliar with biosimilars. Education is key to building physician and patient confidence. Current legislation in Congress also offers hope for the interchangeability of biosimilars. This legislation references insulin biosimilar products, and if it successfully passes it would mean that once an insulin biosimilar product has achieved FDA approval, it can automatically be interchanged. For the first time, pharmacists could potentially enable patients to switch to a biosimilar. Education will be needed on what interchangeable means to ensure patients and physicians know they are safe and effective.



There is still plenty of progress to be made to increase the adoption of biosimilars across the US and there is also a growing need to reduce healthcare costs as a result of the pressures from Covid-19. Many are positive about what the next year will hold and even more so what the next 5 years will hold especially with the hopes of the first interchangeable insulin biosimilar launching soon. However, there are still some clear barriers in the form of rebate contracting and patent litigation as well as physician and patient awareness and confidence. I would love to hear your thoughts on how we can encourage further adoption and what progress will be made this year. Email me directly