Biosimilars on the Cusp of Explosive Growth

The biosimilars market in the United States is poised to experience significant growth in the coming year and beyond, driven—in part—by greater uptake and an acceleration in FDA approvals and product launches.

Slowed by disruptions caused by the COVID-19 pandemic, the biosimilars market has rebounded in 2022 as the FDA has approved six products, including the first biosimilars within retina-ophthalmology. The approved products—which nearly match the total (7) from the two previous years combined—offer the potential to expand patient access to high-quality biologics and generate cost savings across healthcare. In fact, since the first biosimilar approval in 2015, biosimilars have generated more than $13 billion in savings.

And more movement is on the horizon. With at least seven biosimilars referencing AbbVie’s blockbuster Humira (adalimumab) set to launch in the coming year, 2023 could serve as a pivotal time for the industry.

Preparing for adalimumab biosimilars

Humira, which is used to treat an array of inflammatory diseases, is the world’s top-selling pharmaceutical product, generating upward of $20 billion in revenue in 2021. To date, the FDA has approved seven biosimilars referencing Humira, with Amgen’s biosimilar set to launch in the first quarter of 2023.

Many pharmaceutical industry stakeholders are closely monitoring decisions made around wholesale acquisition cost (WAC), PBM (pharmacy benefits manager) coverage, support services and patient and provider education, said Beth McMahon, Senior Vice President for Global Emerging Therapies and Channel Strategies at AmerisourceBergen, a global healthcare company. Optum Rx recently announced it plans to place up to three of the biosimilars on its formulary at parity with Humira.

“It will be interesting to follow the unprecedented competition in the adalimumab market and monitor how it helps to drive cost savings across healthcare,” McMahon said. “Knowing that the majority of the approved Humira biosimilars are set to launch in mid-2023, I anticipate we will see more widespread adoption by PBMs in 2024.”

Implications of Inflation Reduction Act on Biosimilars Market

While the biosimilars market is poised to experience tremendous growth in the U.S., new legislation – most notably, the Inflation Reduction Act of 2022 (IRA) – has introduced measures that have the potential to impact the biosimilars market. 

The Centers for Medicare & Medicaid Services (CMS) recently finalized the proposed rule to continue its policy to make all biosimilars eligible for pass-through payment—and not just the first biosimilar biological product for a reference product.

Starting in October, per the Inflation Reduction Act, we saw an increase in reimbursement for Medicare Part B biosimilar products. Specifically, the temporary add-on payment for qualifying biosimilar biological products jumped from 6% to 8% of the average sales price (ASP) of the reference product for a five-year period, said Corey Ford, Vice President of Reimbursement and Policy Insights at AmerisourceBergen. A “qualifying biosimilar” has an ASP that is less than the ASP of the reference product.

However, questions remain about the potential impact of the Inflation Reduction Act on the biosimilars market long-term and how it will influence companies that are deciding to make a push into biosimilars. So far, that doesn’t seem to be the case – just last week Teva Pharmaceutical Industries and Sandoz said they are planning a significant ramp-up in production of biosimilars.

Driving Awareness Among Healthcare Providers, Patients

While the tremendous momentum offers significant potential for the healthcare system and patients, there is a heightened demand for education, said Brian Biehn, senior director of Biosimilar Commercialization at AmerisourceBergen.

Research published in June—prior to the launch of the two ophthalmology biosimilars (Byooviz and Cimerli)—revealed that the majority of ophthalmologists surveyed were not very familiar with Byooviz, the first ophthalmology biosimilar, and only 16% were aware of the launch date in 2022.

“The need for education cannot be overstated, particularly as biosimilars expand into new therapeutic areas and more pharmacy benefit biosimilars launch in the United States,” said Biehn, who recently spoke on a panel at GRx+Biosims 2022 titled, “What to expect from the biosimilars market in 2023.” “Education is critical to close ongoing gaps in biosimilar adoption, combat misinformation and drive provider and patient awareness and acceptance.”

Providers need to understand what products are available, how to prescribe them, what the interchangeability designation and process is in their state and how the products are being covered. Continued education on interchangeability is also important, as there is a misconception that interchangeable biosimilars are superior to those without the designation – when it really means that depending on state laws a pharmacist-level substitution will be allowed.

AmerisourceBergen, Biehn said, leverages its role in the pharmaceutical supply chain and its suite of services—from distribution and commercialization to provider solutions and patient support—to help expand access and instill confidence in biosimilars.

In addition to working alongside biopharma companies to help them move from clinical development to commercialization, teams across AmerisourceBergen play a vital role in delivering critical education and support to providers, including specialty physician practices and independent community pharmacies. Providers also have access to a variety of educational resources, such as AmerisourceBergen’s recently published biosimilars pipeline report and an interactive dashboard that outlines the state-by-state substitution laws.

“We are committed to uniting stakeholders across the healthcare continuum to support the biosimilar channel and expand access to these medicines,” McMahon said.

To learn more about AmerisourceBergen’s role in the pharmaceutical supply chain and the solutions it offers for increasing access to and confidence in biosimilars, check out:

The editorial staff had no role in this post's creation.