The Promise of Biosimilars: Trends in 2021 and Beyond


Biosimilars offer savings opportunities to help mitigate the growing and costly biologic specialty drug market through competition. While 2020 saw a decrease in biosimilars activity with fewer approvals and product launches, the U.S. saw an increase in biosimilars uptake during that timeframe, suggesting that the market is poised for continued growth.

Hospitals and health systems have faced intense financial and economic pressures due to the pandemic, having to adjust how care is delivered in clinics and acute care settings. COVID-19 has created an opportunity for biosimilars to continue to provide access, affordability and savings. Many hospitals are looking at how to adopt biosimilars at a higher rate to help drive cost savings.

“Many more hospitals are using biosimilars. It’s becoming almost a standard of care,” says Julie Rubin, CompleteRx director of clinical services. However, Rubin adds that mixed payer coverage has hindered faster uptake of biosimilars and means that many hospitals must carry multiple products to meet payer requirements.


Notable biosimilar market entrants

2020 saw just three biosimilar approvals from the FDA, compared to a record-breaking 10 in 2019. According to Rubin, experts predict 2021 and beyond will bring an uptick in biosimilar approvals and product launches. These additional biosimilars will increase competition, access and affordability.

The first insulin biosimilar approval and product launch are on the horizon, with additional biosimilars expected to follow. Multiple entrants are also expected to launch in the Humira space in the next couple of years.


Shifting policies support biosimilar adoption and innovation

Coming out of the 2020 election cycle presents the potential for government policies that support the biosimilar market. For example, last fall, HR 8190 was proposed to make insulin biosimilars automatically interchangeable upon approval. Although the bill ultimately died in Congress, it helped shine some light around interchangeability, which enables pharmacists to fill prescriptions with lower-cost biosimilars without a prescribing physician’s authorization.

In April, President Biden signed the Advancing Education on Biosimilars Act into law. The act, which received bipartisan support, calls for the government to provide educational materials, including infographics, continuing education programs and webinars, to doctors and the public to increase awareness and knowledge about biosimilar drugs. Supporters hope that educating providers and patients about biosimilar products will increase confidence in the safety and effectiveness of the drugs and lead to an increase in biosimilar prescribing, which could ultimately help lower overall drug costs.

Other recent legislation would direct the Department of Health and Human Services to launch a pilot program with increased Medicare payments for providers who use biosimilars. Yet another bipartisan bill in the House would push Medicare Advantage plans to increase biosimilar access by evaluating plans on biosimilars coverage in its Star ratings program.


Evolving payer coverage

Mixed payer coverage continues to create challenges for the biosimilar market. Equal treatment in terms of payer coverage between biologics and biosimilars will lead to faster adoption, foster competition and lower drug costs. It will also allow providers to make clinical decisions in the best interest of their patients without being restricted by payer requirements and mandates.

Rubin notes that payers are beginning to evolve and expand coverage of biosimilars and that trend will likely continue. “As multiple biosimilars for a reference product become available, that competition is bringing down prices,” notes Rubin. “Payers are increasingly providing reimbursement for biosimilars to encourage their use.”

Biosimilars continue to be an essential tool to expanding access to biologic therapies, increasing patient and physician treatment choice, and addressing healthcare costs. Going forward, continued payment and reimbursement policies that advance the uptake of lower-cost biosimilar products will be essential.

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