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Biosimilars 2022: Realizing the potential in the year ahead

By Heidi Hunter, President, Cardinal Health Specialty Solutions

 

Note: Cardinal Health distributes biosimilars across all the sites of care where they are approved for use – including physician offices, health systems and retail and specialty pharmacies nationwide. We provide the education, analytics and technology to help care providers and pharmacy networks make informed decisions about how they can adopt biosimilars. In addition, Cardinal Health Specialty Solutions works directly with biosimilar manufacturers to help them navigate the path toward clinical development, regulatory approval and commercialization. To learn more, please read What are biosimilars?

Biosimilars are forecasted to deliver more than $133 billion in aggregate savings by 2025. More importantly, the total savings to patient out-of-pocket costs, based on the current biologics with approved biosimilars, are estimated to reach up to $238 million. With more than 40 different reference products being discussed for biosimilar development, the momentum for bringing biosimilars to market is stronger than ever.

Over the past seven years since the first biosimilar was approved in the U.S., biosimilars have been primarily focused on oncology and, to a lesser extent, rheumatology. However, over the next five years, there will be more opportunities to bring biosimilars to a broader patient population across diabetes, ophthalmology, and most notably, immunology.

2022 is set to be a turning point in the U.S., as biosimilars expand into new therapeutic areas and sites of care, and as reimbursement models continue to evolve. Here are five trends I believe are particularly worth watching.

 

1. Insulin biosimilars will reveal how managed care stakeholders will respond to interchangeable biosimilars, and retail pharmacists will be positioned as key change agents

As the first biosimilar product to fall under the pharmacy benefit in Medicare Part D, insulin will serve as the ultimate case study, revealing how managed care will evaluate and position these products – and how payers and pharmacy benefit managers (PBMs) will design plans and formularies to deliver the greatest savings to patients. Managed care stakeholders have the opportunity to be catalysts for biosimilar adoption, bringing much-needed competition to the market. The question of how quickly they will embrace this opportunity is likely to be answered this year.

Retail pharmacists also will play a critical role in delivering the promise of biosimilars to their patients and communities. Now that Semglee (insulin glargine-yfgn) is designated as interchangeable, pharmacists can substitute it in place of its reference product without prior prescriber approval, per state laws. As a result, pharmacists are positioned to play an essential role in educating patients and ensuring clinical confidence in biosimilars, and also to serve as key change agents – potentially steering millions of diabetes patients to high-quality, lower-cost treatment options.

 

2. Manufacturers of reference biologics will take further steps to protect their market share in preparation for the 2023 launch of Humira biosimilars

Beginning next year, AbbVie’s Humira (adalimumab) – the all-time top selling drug in the world – will face competition from as many as seven biosimilar competitors that have already received FDA approval, and from several more candidates in the pipeline. The impact on the rheumatology and immunology market could be dramatic – not just for Humira, but for all immunology therapies in the class, including Janssen’s Stelara (ustekinumab) and Genentech’s Actemra (tocilizumab), which are also expected to face biosimilar competition over the next few years.

Several innovator biologic companies have taken steps to defend their market position by raising prices, creating new formulations or generating new innovative therapies. For example, according to a 2021 report from the House Committee on Oversight and Reform, the list price of Humira has increased 27 times, leading to a current price that is 470% higher than when the drug launched in 2003. Other reference product manufacturers have employed similar pricing strategies. As a result, when biosimilars come to market, branded biologic manufacturers will be in a position to offer deep rebates to payers and PBMs, which may in turn keep its net price on par with – or even lower than – biosimilar competitors.

Some companies have added new formulations and delivery mechanisms, such as autoinjector devices, which, in addition to providing patients with more treatment options, also extend patent protection. We expect more advancements in formulations and administration mechanisms this year and beyond.

We’ll see more focus from innovator companies on transitioning patients to completely new treatment options, seeking to advance the path toward obsolescence of biosimilars and originator biologics. It’s likely that several branded biologic companies may introduce their own “authorized biologic” versions of products at lower prices ahead of biosimilars launches, which could protect patient share and help fend off competition.

However, the manufacturers of adalimumab biosimilars potentially have much to gain in 2023 – and they know the competition for share will be fierce. We anticipate some may launch market conditioning and educational campaigns in 2022 to establish brand awareness and educate prescribers, patients and pharmacists in advance of the biosimilars’ arrival in 2023.

 

3. Biosimilar uptake in ophthalmology will be slow, as a focus on retinal care innovation continues

The number of patients diagnosed with wet age-related macular degeneration (AMD), the world’s leading cause of blindness in older adults, continues to grow annually; the National Eye Institute predicts the number of cases will more than double by 2050. With an average per-patient annual cost of $2,000 per treatment, the biotech industry is focused on developing more effective AMD therapies and delivering treatment options that lower the cost of care.

A lower cost of care may come with the launch of Byooviz (ranibizumab-nuna), the first biosimilar in ophthalmology, which was approved in September 2021 and is expected to launch in June this year.

The market entrance of biosimilars to Lucentis (ranibizumab) may also bring the potential for broader treatment access and lower costs for AMD patients, but we anticipate that biosimilar uptake in ophthalmology may be slower than other therapeutic areas for several reasons. First, the U.S. achieved one of the first ophthalmology biosimilar approvals in the world (unlike oncology and rheumatology biosimilars, which were initially approved in Europe), meaning that there is limited real-world data for physicians to reference. In addition, research conducted with ophthalmologists and retina specialists in 2021 shows a high level of skepticism about biosimilars, indicating a strong need for education and additional outcomes data to help build confidence among prescribers.

Another factor is the innovator therapies that have recently launched or are expected to come to market soon to treat AMD, including Roche’s new port delivery system, Susvimo with ranibizumab, faricimab and several gene therapies in development. As these new – and possibly more effective – treatments come to market, physicians will have more options to select from and standards of care for AMD will continue to evolve. Even though the launch of new innovative therapies could lead to slower uptake of biosimilars, they should also lead to a wider range of treatment options and better outcomes for patients.

 

4. The U.S. will see more pro-biosimilar health care policies at both the federal and state levels

In 2021, President Biden demonstrated strong support for biosimilars. In addition to signing an Executive Order directing the Food and Drug Administration (FDA) to make the biosimilar approval process more transparent, in a report outlining recommendations on lowering the cost of prescription drugs, his administration called for market changes that would promote the use of biosimilars.

We expect to see more pro-biosimilar focus in the future, including additional rulemaking by the FDA – as well as Federal Trade Commission (FTC) action – to support competition and enhance consumer choice by preventing efforts by reference product manufacturers to delay or block competition from biosimilar and interchangeable products. According to the October 2021 white paper “Innovation Strategy Center Refresh,” the Center for Medicare & Medicaid Innovation (CMMI) is expected to design models that incentivize the use of biosimilars in Medicare Parts B and D, to lower beneficiary and program spending on drugs. And the Centers for Medicare & Medicaid Services (CMS) may issue guidance to ensure that biosimilars are covered under Medicare Part D. CMS may also pursue additional policies, including the removal of prior authorizations and other utilization hurdles, and reductions in patient cost sharing in order to drive increased adoption.

In addition, as states continue efforts to lower drug costs, we expect state legislatures this year to introduce policies – like requiring health plans and PBMs to cover all versions of biological agents, including biosimilars – that will broaden access to biosimilars.

 

5. Biosimilars manufacturers and commercial partners will increasingly turn to real-world evidence (RWE) to demonstrate equivalency to providers and payers

Understanding of biosimilars among prescribers continues to grow, but many health care providers still question whether biosimilars can deliver the same outcomes for patients as their reference products. As biosimilar manufacturers face increased pressure to demonstrate safety and efficacy, they will increasingly invest in RWE studies, which are not only less expensive to implement than randomized controlled trials, but also more representative of the patient populations in the real world. This data will be particularly relevant in ophthalmology, where today there is limited RWE available.

RWE studies also will provide valuable insights into whether switching patients between biosimilars of the same molecule has an impact on patient outcomes; that will become a more important question as more biosimilars come to market – specifically in categories such as immunology where there could be seven or more biosimilars referencing a single branded product.

Finally, with more than 15 years and two billion patient days of biosimilars experience in the EU, sharing of global resources and data represents one of the greatest opportunities to strengthen biosimilar acceptance in the U.S.

We expect RWE to play a key role in advancing the development and approval of biosimilars that are still early in the pipeline, and to provide data to help products meet the regulatory standards necessary for interchangeability designation.

 

Looking ahead

Beyond 2022, the successful adoption of biosimilars will create broader health care access and lower costs for patients. It will also free health care dollars systemwide to enable more investment in advanced, innovative treatments, such as cell and gene therapies, with the potential to drive overall improvements in both rare diseases and public health.

Although there are still barriers to overcome, the promise of biosimilars outlined in the Biologics Price Competition and Innovation Act (BPCIA) are starting to be realized. As momentum around biosimilars in the U.S. continues to accelerate, patients will experience expanded benefits through broader access to and affordability of life saving medications.

 

A version of this article first appeared in the 2022 Cardinal Health Biosimilars Report: The U.S. Journey and Path Ahead, which brings together Cardinal Health health care provider survey results and the latest market data on biosimilar utilization and payer coverage, along with perspectives from leading physicians and industry experts. You can download a free copy of the report here.

 

As President of Cardinal Health Specialty Solutions, Heidi Hunter leads the specialty health care business that helps providers and pharmaceutical companies optimize business success and drive improved patient care. Hunter is an accomplished global health care leader with deep experience in innovation, development and commercialization of specialty pharmaceuticals.