With 2023 poised to be the year of the adalimumab (Humira, AbbVie) biosimilar wave, a new report focuses on market expansion and sustainability for biosimilars in the United States.

According to the report, issued by Cardinal Health, gastroenterologists appeared to be comfortable with the prospect of prescribing a Humira biosimilar, with 93% saying they were at least somewhat comfortable and 50% very comfortable. Safety and efficacy as well as overall issues with switching were the most often cited concerns.

The first adalimumab biosimilar, adalimumab-atto (Amjevita, Amgen), entered the U.S. market on Jan. 31, after six years of regulatory delay. At least seven more adalimumab biosimilars are expected to debut later this year, likely in July. Clinical and real-world evidence, and patient out-of-pocket cost, could play important roles in further differentiating this potentially crowded market.

“Providers have a reference-brand product they’ve been using for decades, with a tremendous amount of research data accumulated around it,” said Bruce Feinberg, MD, the vice president and chief medical officer of Cardinal Health. “They are likely to be disinclined to want to switch patients from the reference brand who are stable and in an improved state from when they first started.”

Boehringer Ingelheim’s adalimumab-adbm (Cyltezo), which became the first biosimilar interchangeable with adalimumab in October 2021, may have the early advantage. At least four additional adalimumab biosimilar manufacturers are pursuing interchangeability, according to the Cardinal Health report.

Alternatively, manufacturers could focus on other factors such as concentration, injectable formulations or pill size. Competitive pricing offers another opportunity for biosimilar manufacturers to stand out, Dr. Feinberg said.

Patients also may have preferences, noted Shubha Bhat, PharmD, a clinical pharmacy specialist in gastroenterology and clinical assistant professor of medicine at Cleveland Clinic, in Ohio. “Previous biosimilar products used for autoimmune conditions were primarily infusion-based, so patients didn’t observe any differences unless they looked at the label. Since adalimumab biosimilars are being dispensed from the pharmacy for self-administration, patients will be aware of the different product characteristics.”

With so many biosimilars for one originator product entering the market within the same year, adalimumab represents “the true test case of what the impact of extreme biosimilar competition can be,” said Ameet Sarpatwari, PhD, JD, an assistant professor of medicine at Harvard Medical School, in Boston. Dr. Sarpatwari said he expects to see U.S. price reductions from biosimilars ranging between 20% and 30%.

—Gina Shaw