Anticipating the 2023 Biosimilar Boom

A Brief Description of Biosimilars

According to the American Cancer Society (ACS), biosimilars are medications that function similarly to brand-name biologics. Many people mistake biosimilars for generic medicines. While similar in some respects, generic drugs refer to smaller chemical compounds, while biosimilars are large complex molecules.

Diseases Biosimilars Are Used For

Oskouei highlighted the main uses for biosimilars, specifically in the rheumatology space. “These are used for immune-mediated inflammatory diseases, including many rheumatologic conditions. These include rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and additional inflammatory conditions like Crohn's disease and ulcerative colitis. These are often chronic conditions that could be very severe and debilitating to somebody's quality of life. There are big opportunities to find solutions for patients living with these conditions,” commented Oskouei.

Biosimilars in Rheumatology

In a recent insights report by Cardinal Health, the company found that familiarity and comfortability surrounding biosimilars in rheumatology have grown between 2020 and 2022. In 2020, just over half, 53%, of rheumatologists reported being “very familiar” with biosimilars. A 2022 analysis found that the number jumped to 76%. Additionally, in 2022, 62% of rheumatologists felt “very comfortable” prescribing biosimilars, a 21% increase from 2020.

History of Biosimilars in Rheumatology

As previously mentioned, biosimilars are best understood and widely used in oncology. According to an American Health and Drug Benefits publication, the first biosimilar was an oncology drug called Zarxio, which received FDA approval on March 6, 2015. A year following the approval of Zarxio, the first rheumatologic biosimilar was approved.

Oskouei revealed, “the first rheumatology biosimilar became available in 2016. Since then, 6 products have been on the market with a rheumatologic indication. To put it in perspective, the pharmaceutical industry has 24 biosimilars today. So far, the vast majority of activity has been in the oncology space, but then we have a handful of rheumatology biosimilars, and that's expected to grow.”

Growing Comfort and Familiarity

This growing familiarity can partially be attributed to an increased understanding of these medications, rooted in additional research, publicity, and collaboration on biosimilars and their uses. In a discussion with PharmaNewsIntelligence, Oskouei mentioned that the biosimilar space had been a relatively small community for the past seven years. As the community has broadened its reach and expanded into additional fields, more patients, providers, and payers have learned what biosimilars are and their uses.

Oskouei states that the increase in comfort and familiarity of biosimilars among rheumatologists is driven by overall growth, utilization, and exposure of these products.

Additionally, she notes, “in the past couple of years, the industry has started to see increasing growth in the rheumatology biosimilars. That could correlate with multiple factors. But in Cardinal Health’s 2022 biosimilars report, we've done market assessments where we have almost seen strong correlations between payer activity and rheumatology biosimilar utilization. Increasing payer coverage and that type of activity has supported the use of these agents, especially more recently.”

“The growth in familiarity and comfort, first and foremost, is just increased time and experience of these products on the market and the growing number of products on the market,” emphasized Oskouei. “The second reason is anticipation of 2023. This is a landmark year that many stakeholders are excited to see play out and eager to see it play out.”

Understanding Approvals and Market Exclusivity of Biosimilars

Oskouei discussed the impacts of market exclusivity on the availability and growth of the biosimilar market in her interview with PharmaNewsIntelligence.

“In the US, when biologics get approved, they get 12 years of market exclusivity, which from what I know, is the highest anywhere in the world,” she explained. “That's an incentive to innovate and create new biologics.”

Despite the intended incentive, many pharmaceutical companies have abused the market exclusivity and patent system. The biosimilar landscape faces the same issues that generics face regarding patent laws and market exclusivity.

“In the US, often the innovator products get even longer than those 12 years because of the patents placed and associated with their products,” added Oskouei. And these patents can be for multiple things. It could be a formulation, device, or buffer in the formulation. The sky's the limit, apparently, regarding what you can patent. But that plays a role in the delays of launches of products that have already been FDA approved.”

Market exclusivity or patents on specific formulations prevent the development and rollout of similar products — in biologics, this means biosimilars. This reduces the competition, allowing the company that holds the patent or has market exclusivity to drive up costs.

A publication from the Commonwealth Fund lists Abbvie as an example of patent abuse, stating that the company has filed for 225 patents on Humira. These patents and the inability to develop alternate versions of the medication have contributed to nearly $19 billion in healthcare costs. 

“Given the number of patents put on these products, when a biosimilar is trying to compete, there's a litigation process that occurs which can potentially, based on the settlement, delay the launch of the biosimilar to come to market,” Oskouei continued.

Combatting Abuse of Market Exclusivity and the Patent System

These issues have contributed to billions of dollars in additional healthcare spending and barriers to access to care. Despite ongoing problems, Oskouei and others are hopeful that policy changes will help mitigate future and continuing abuse.

“Last year, a bipartisan law was passed to tackle some of this. It's a big area of focus for policy work,” she noted. “Congress passed — and Biden signed — the Ensuring Innovation Act, an act that was passed to ensure that any exclusivity period granted to a product was based on true innovation and not as a means to delay competition.”

The Impact of Biosimilars on Health Equity

Oskouei touched on how biosimilars may help bridge gaps in health equity, noting that there are existing healthcare disparities based on race, ethnicity, income, education, gender, disabilities, and many more.

“With biosimilars, when thinking about the promise of these agents, it is to bring competition, lower costs, and enhance accessibility and affordability of critical treatments,” maintained Oskouei. “That is the core of what biosimilars are here to do. So that is a key strategy to help address some of these healthcare disparities and meet needs from various social determinants of health. We know, for example, in rheumatology, several rheumatologic conditions impact women more than men, and being able to bring more treatment options to market that could create more affordable care is a huge strategy.”

Clinical Trials

In addition to the potential to reduce costs, Oskouei mentions the unique opportunity that biosimilars and biosimilar developers have when addressing racial and ethnic inequities. “Patients of color make up 40% of the rheumatoid arthritis population but only account for 16% of clinical trial participants,” she began, quoting the insight report.

With that in mind, “the FDA has had heightened focus and interest around leveraging real-world evidence to support regulatory decision making for biosimilars. So, all these different strategies ultimately come together to meet the needs of patients and our diverse populations in the country,” concluded Oskouei.

Looking Ahead

Oskouei, like many others, predicts a revolutionary year for biosimilars in 2023. “This is an exciting space. The industry is in this milestone year and pivotal moment in US biosimilar history. Not only will we see a shift with more immunology biosimilar agents, but we're seeing growth in huge heavy hitters like the adalimumab products and others: Actemra, Stelara, and so on,” concluded Oskouei.

As 2022 ends and the new year begins, providers, patients, payers, and everyone in between will patiently await in anticipation of the biosimilar boom. The perceived benefits of these treatments are unparalleled for patients who require biologics to manage their chronic conditions. Despite the potential for reduced medication cost, increased accessibility, and improved health equity, the outcomes heavily rely on proper regulation and uptake of these tools.