January 09, 2024

US biosimilar market in 2023: Sea change or slow drip?

News pertaining to biosimilars came at a fast and furious pace in 2023.

This was the year of the big “deluge” in biosimilars, including those designated as interchangeable, hitting the rheumatology market in the United States. As many as nine biosimilars for adalimumab (Humira, AbbVie) alone became available for the first time for U.S. patients, with other biosimilars for ustekinumab (Stelara, Amgen) and tocilizumab (Actemra, Genentech) making headlines.

Below are some of the news and feature highlights to help readers gain a deeper understanding of how patient care and prescribing habits might continue to evolve through 2024.

In December 2022, Healio previewed the expected and potential changes in the biosimilar market in the United States. Ultimately, nine biosimilars entered the U.S. market in 2023, initiating what some saw as a “sea change,” or at least the beginning of what could be a years-long shift in prescribing habits and patient management.

Take a look back to see how the predictions played out over the course of 2023.

A critical component of successful biosimilar implementation will be buy-in from clinicians. In a survey conducted by Cardinal Health, just 18% of responding rheumatologists felt that the economic benefits of prescribing these medications warranted a switch from the bio-originator. Jeffrey R. Curtis, MD, MS, MPH, of the University of Alabama at Birmingham, coauthor of the 2023 Biosimilar Report, suggested that many rheumatologists believe biosimilars offer “little upside.”

“Ensuring that all stakeholders’ needs are met to affect a smooth transition to biosimilars remains an important challenge in the year to come,” he said.

Halfway through 2023, Spherix Global Insights conducted a quarterly analysis of biosimilar uptake in light of Amgen’s adalimumab biosimilar, Amjevita, debut in January. Results of the physician survey published in June showed that uptake remained “low” at that time point.

The study included 81 dermatologists, 77 gastroenterologists and 85 rheumatologists. One respondent quoted by the organization suggested that if Humira is working, “don’t mess with success by switching to a biosimilar.”

In June, Johnson & Johnson settled its lawsuit with Amgen regarding the latter company’s Stelara biosimilar, clearing the way for a January 2025 release date in the United States, according to results of a federal court filing. Whether the development will lead to cost savings and increased access remains to be seen.

The launch of the adalimumab biosimilar Cyltezo (Boehringer Ingelheim) on July 1 marked a potential paradigm shift in the biosimilar conversation in the United States. Unlike previous adalimumab biosimilars, this drug had been designated as interchangeable, meaning that it can be swapped at the pharmacy in place of the reference product, or other biosimilar, without consulting the prescribing physician, as per law of the state where the prescribing takes place.

Some experts view this development as another potential sea change in the biosimilar marketplace, while others view it as just one step in a long shift in rheumatology prescribing habits.

The concept of interchangeability underwent more comprehensive scrutiny in a July cover story in Healio Rheumatology.

Experts from the publication’s deep bench of market watchdogs, including Madelaine A. Feldman, MD, FACR, vice president of advocacy and government affairs at the Coalition of State Rheumatology Organizations, weighed in on the approval of Cyltezo and the “great American switching experiment.”

October saw the emergence of Tofidence (Biogen), the first tocilizumab biosimilar to gain FDA approval. The approval came on the heels of two studies showing the product’s safety and efficacy. No timeline is set for when the drug will be available in the United States. However, it is known that indications will include rheumatoid arthritis in adults, as well as polyarticular juvenile arthritis and systemic juvenile idiopathic arthritis in those aged 2 years and older.

Also in October, the FDA approved the second interchangeable adalimumab biosimilar, the Pfizer product Abrilada. As with Cyltezo, the impact of the interchangeability designation varies depending on the state.

It is likely too soon to tell whether a second interchangeable product on the market will impact pricing, but it likely will impact the medications that some patients end up taking.