Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

January 06, 2020
6 min read

Provider education, practice champions can ensure successful integration of biosimilars into oncology care

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Kashyap Patel, MD
Kashyap Patel

By Kashyap Patel, MD

Hundreds of millions of people worldwide rely on biologics to manage debilitating conditions and treat serious illnesses.

These innovative therapies are particularly significant for patients with cancer, as they provide an alternative to hours of chemotherapy.

As the patents of many biologics expire, opportunities to introduce biosimilar products are increasing.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

These therapies are launched at lower prices than existing biologics and are introducing competition into these markets.

The emergence of biosimilars potentially can reduce health care costs, while also providing patients and physicians with greater access to and choice of more affordable treatments. In fact, with the adoption of biosimilars, it is projected that the United States can decrease direct spending on biologics by $54 billion between 2017 and 2026.

However, biosimilars only will lower health care costs if physicians are willing to adopt them into their prescribing.

Biosimilar spending has doubled since 2017, but it still represents less than 2% of the total U.S. biologics market.

To put this into perspective, it has taken filgrastim-sndz (Zarxio, Sandoz) — the first commercialized biosimilar in the United States — nearly 5 years to achieve a 32% share of the filgrastim market.

The impact of brands losing exclusivity is expected to generate savings of $78 billion over the next 5 years if physicians — and specifically oncologists — support the biosimilar platform.

The next big wave of biosimilars to launch will target cancers, meaning oncologist uptake will be critical to ensure the biosimilar platform continues to expand.

Fifteen of the 25 FDA-approved biosimilars are indicated for oncologic diseases, and half of those oncology drugs already are on the market.

By the end of 2020, the United States could see as many as five biosimilars competing with trastuzumab (Herceptin, Genentech), which targets certain types of breast and stomach cancers.

If oncologists begin to support biosimilars, we can expect to see biosimilar competition within the oncology market lead to lower prices and an increase in patient access in the coming years.

Physician acceptance of biosimilars and implementation of these agent’s into a practice’s workflow can be achieved through five key steps.


1. Enable provider education.

AmerisourceBergen, a global health care solutions company, conducted its Biosimilar Checkup survey of 100 physicians to get their insights on biosimilar adoption and cost.

The results, released in September, showed 74% of respondents identified physician confidence as one of the biggest barriers to widespread adoption of biosimilars.

Nearly 50% indicated they were not confident switching a patient to a biosimilar during an active treatment regimen.

Less than half of respondents reported having some level of basic background knowledge on biosimilars, including an understanding of biosimilarity, the approval process, approved biosimilars and indications, and the U.S. biosimilar pipeline.

I conducted a poll last fall at ION Solutions’ Large Practice Program National Meeting, and I was surprised to learn that almost 40% of respondents were unaware of the key factors that make up the FDA approval process for biosimilars.

As oncologists, we need to understand the FDA 351(k) approval pathway and the standards by which these new therapies are measured in order to feel confident enough to prescribe biosimilars to our patients or shift their treatment plan to include biosimilars.

I encourage physicians to engage with industry associations (eg, ASCO), manufacturers and government agencies for further educational resources and opportunities to get answers to their questions and concerns. Gaining clarity on these issues also will better position us to answer patient questions when biosimilars become more commonplace.

2. Appoint a biosimilar champion.

Once there is a concrete understanding of biosimilars as a class, integrating these products into an oncology practice still can seem intimidating given the novelty of these therapies.

I recommend that cancer care providers appoint a “biosimilar champion” to spearhead implementation and make the transition as efficient and cost-effective as possible.

This champion ideally should be an existing staff member — such as a nurse or pharmacist — who is familiar with clinical and patient flow and has a grasp of how the entire practice operates.

The champion can save physicians valuable time by doing background research on biosimilars and ensuring the practice is using all resources — including patient support programs — available to them through manufacturers. The champion also can spearhead and oversee many of the best practices shared below.

3. Conduct critical research before prescribing.

It is important that oncologists or their practices’ biosimilar champions conduct research on both the biosimilar and its manufacturer before deciding to prescribe a therapy.


Physicians must develop an in-depth understanding of how the biosimilar works, its indications and its potential side effects. This knowledge will help oncologists make the best prescribing decisions.

However, it also is critical for physicians to evaluate each biosimilar’s manufacturer. Knowledge of how long a manufacturer has been in the marketplace will reveal whether a supply chain for its biosimilar is established and stable.

It also is a good sign if a manufacturer has a reputable distribution partner. Such partners connect biosimilar manufacturers with channel management strategies, and provide access to the tools needed for implementing patient assistance and drug replacement program.

4. Navigate coverage needs.

It is imperative that oncologists are equipped to navigate the complexities of payer coverage of biosimilars. This is where technology can be invaluable.

I recommend investing in an automated benefit verification system if a practice doesn’t already have one in place. This tool significantly streamlines the process of determining local coverage eligibility and accessing details on out-of-pocket costs for patients.

Most of these systems can monitor, communicate and update changes to health plans and formularies. This is particularly important when dealing with novel therapies and a relatively new class of medicines.

These systems also possess a high level of accuracy and quality, saving practices time and reducing the need for re-work — ultimately leading to faster access to treatment options for patients.

5. Master data reporting under Oncology Care Model.

Finally, oncologists can use biosimilars to achieve significant reimbursement benefits as they evolve toward value-based care models.

Many oncology practices already are participating in the Oncology Care Model (OCM), an episode-based payment model that encourages practices to improve patient care and lower costs through financial incentives.

Oncologists receive significant reimbursement under the OCM if they can demonstrate they are providing the same or better care at a lower cost than other physicians.

Naturally, prescribing a lower-cost biologic-based therapy is a great solution for fulfilling these requirements. Biosimilars also uniquely include patient support services or different dosing and packaging options that make these therapies a great fit for the OCM.

Before they can achieve reimbursement benefits, oncologists need to master the process for data collection and reporting required by Center for Medicare & Medicaid Innovation. This means capturing, reporting and submitting data that demonstrate how the success their practice has achieved through biosimilars fulfills OCM value-based objectives.


A practice can have their biosimilar champion spearhead this collection, as well as employ a quality reporting engagement team to provide guidance.

This team will work together with a practice to evolve quality measurements. They will connect a practice with real-time performance insights, analytics tools and other technologies that will help them improve their prescribing and treatment methods.

With this level of support, oncologists can identify value-based care gaps and pinpoint solutions, ultimately ensuring practices avoid expensive mistakes while also maximizing reimbursement.


Biosimilars are critical to the future of cancer care.

There are at least four biosimilars for oncological diseases expected to launch in 2020. These agents will increase competition significantly within the oncology drug market and help drive patient access to critical care.

It is important for oncologists to capitalize on these launches so we can begin to experience the potential savings, expand access and choice, and — more importantly — offer the greatest number of patients the best care possible.

We have an obligation to educate ourselves and one another about this new platform and implement its therapies in our care plans.


AmerisourceBergen. Biosimilars Check Up: Physician Survey Results. Available at: Accessed on Dec. 22, 2019.

Gifoni M, et al. J Glob Oncol. 2018;doi:10.1200/JGO.2016.008342.

Mulcahy AW, et al. Rand Health Q. 2018;7:3.

The IQVIA Institute for Human Data Science. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. 2019. Available at: Accessed on Dec. 22, 2019.

For more information:

Kashyap Patel, MD, is CEO of Carolina Blood and Cancer Care. He also is vice president of Community Oncology Alliance. He can be reached at Carolina Blood and Cancer Care, 1583 Healthcare Drive, Rock Hill, SC 29732; email:

Disclosure: Patel reports no relevant financial disclosures.