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Progress and Challenges in the US Biosimilar Space


Editorial board member Brian Lehman, MBA, MHA, RPh, examines current progress and challenges that biosimilars face in the US context, and argues that stakeholders have the opportunity to be part of the solution to high drug prices by supporting biosimilars.

By Brian Lehman, MBA, MHA, RPhDirector, Medical Account Management and Strategic AlliancesSandoz Inc, a Novartis Division

We hear a lot about the problem of skyrocketing healthcare costs, but very few are doing something about it. Biosimilars are one solution to address healthcare costs and give patients access to safe and effective medicines they need and deserve.

Progress in the Biosimilar Space

Biosimilars create the potential to save the US healthcare system $54 billion over 10 years and increase access for an additional estimated 1.2 million US patients by 2025.

Today, 23 biosimilars have been approved by the FDA and 9 are available for use. Savings have been realized by patients, health systems, integrated delivery networks, and payers when switching to biosimilars. For example, Yale New Haven Health System1, Robert Wood Johnson Barnabas Healthcare System2, and Carolina Blood and Cancer Care realized savings when switching to Zarxio® (filgrastim-sndz). And the first biosimilar to be FDA-approved in the US through the BPCIA pathway, Zarxio®, is the first biosimilar to surpass its reference biologic in market share.

As the result of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act and clarifying language included in FDA guidance, starting in March 2020, medicines that include insulins will be regulated as biologics versus drugs or small molecules. This will allow manufacturers to develop their insulin medicines via the biosimilar, or 351(k), pathway. That makes a big difference because currently insulins are regulated in the US as small-molecule drugs and not as biologics. As a result, it is not possible at present to submit an application for a biosimilar insulin. Approval of insulin biosimilars in the future will be significant due to the increase in competition that will help bring down prices for patients and the healthcare system. This will ultimately result in increased access, increased adherence, and reduced complications for individuals who use insulin.

The FDA has become a major champion for acceptance of biosimilars. The FDA has a unique role because it has the trust of patients, prescribers, and many others throughout the US healthcare system. The FDA has developed a wide variety of biosimilar educational materials for healthcare professionals and is working to create educational materials for patients. To complement FDA’s materials, a comprehensive literature review was published, as well as other additional switching studies and supporting statements, that demonstrates that there is no impact on safety or efficacy when switching from a reference medicine to biosimilars.3,4 This review and the underlying studies are of vital importance to further increase provider, payer, and patient confidence in switching.

Challenges in the Biosimilar Space

Sixty percent of FDA-approved biosimilars are not available in US market, such as Sandoz’s biosimilar Erelzi® (etanercept-szzs) that received FDA approval nearly 3 years ago. For those FDA-approved biosimilars that are available in the United States, market adoption has been slow, with some exceptions.

Many obstacles for biosimilars in the United States exist along the path that begins with discovery and development, continues with the process of obtaining regulatory approval, and ends with patients accessing their biosimilar for treatment.

Contributing causes include lack of education and awareness about the benefits of biosimilars, coverage and reimbursement strategies that disadvantage biosimilars, and patent litigation that delays access.

Another challenge is opposition and misinformation on switching from a reference medicine to its biosimilar or biosimilars. Despite the available science and real-world evidence, efforts are underway to influence patients and providers by providing false or misleading information about the safety or efficacy of biosimilars. This is occurring at a time when awareness, perceptions, and knowledge gaps still exist for these stakeholders. This threatens the expansion of biosimilar treatment options, potential improvement of patient outcomes by increasing access to therapies, and supporting medication adherence by providing a clinically equivalent option at a potentially lower cost.

The single biggest challenge that companies face is convincing stakeholders (providers, insurance companies, employers, patient groups, policy makers, and others) that we are at an inflection point that will determine whether the biosimilars market in the United States is viewed as a success or a failure. Actions taken by US healthcare stakeholders send signals back to companies as to whether it is important to continue investing in the development of biosimilars. Negative signals and new or continuing barriers affect whether we realize the future promise of improved savings for the healthcare system and increased patient access in the United States.

By supporting biosimilars, each stakeholder has the opportunity to be part of the solution in offering patients high-quality care at a more affordable price and creating a more sustainable system for patients now and for the future.


1. Leber MB, Abdelghany O, Miller L. Biosimilar adoption: health system challenges and strategies for success. Presented at: 2016 Vizient Clinical Connections Summit; September 29, 2016; Dallas, Texas.

2. Data on file. Robert Wood Johnson Barnabas Healthcare System Raw Sales Data. Sandoz Inc. March 2018.

3. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78(4):463-478. doi: 10.1007/s40265-018-0881-y.

4. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi: 10.1016/j.jaad.2018.11.057.

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