RWE Shows Biosimilar Switching Safe and Effective to Treat Psoriasis

In real-world studies, tumor necrosis factor inhibitor biosimilars to treat psoriasis had comparable safety and efficacy profiles to the biologics. The findings were published in Journal of Dermatological Treatment.

In the United States, there are currently 7 adalimumab biosimilars approved, 2 etanercept biosimilars, and 4 infliximab biosimilars. However, of these 14 biosimilars, only 3 have actually launched in the United States.

The first adalimumab biosimilar, Amjevita, will launch January 2023 based on a settlement agreement with AbbVie, the maker of the originator product, Humira. The 2 etanercept biosimilars will be delayed until 2029, likely, due to a court decision. Of the infliximab biosimilars, only 3 have launched, because Pfizer has decided to withhold the biosimilar Ixifi from the market to avoid competing with Inflectra, which Pfizer also markets in the United States.

In comparison, in the European Union, there are 10 adalimumab biosimilars, 3 etanercept biosimilars, and 4 infliximab biosimilars on the market.

Since the first biosimilars were approved, there have been multiple phase 3 randomized controlled trials that have evaluated outcomes after switching from the reference product to a biosimilar and found biosimilars have similar safety and efficacy. “Real-world data following switching to biosimilars in patients with psoriasis complement data from clinical trials,” the authors wrote.

They conducted a PubMed and Google Scholar search and included 5 observation studies after a single switch from the reference product to an adalimumab biosimilar, 6 observational studies on switching from the originator to an etanercept biosimilar or between etanercept biosimilars, and 6 observational studies and 1 case report evaluating a switch from the reference product to an infliximab biosimilar or between biosimilars.

Adalimumab. The studies found similar efficacy following the switch to the biosimilar in patients with psoriasis. Three studies evaluated articular disease: One found a possible loss of response in patients with axial disease, while the other 2 found no loss of disease control after the switch. The sample size in the study showing a possible loss of response was small. There was an increase in the rate of mild adverse events (AEs) following the switch to the biosimilar in 2 of the 5 studies.

Etanercept. The efficacy of biosimilars to treat cutaneous and articular disease was comparable to the originator after switching, whether it was from the originator to a biosimilar or between biosimilars. Only 1 study found AEs were more common after the switch; however, this study had no control cohort to compare patients who switched and the “AEs were patient reported and subject to bias from a lack of blinding,” the authors noted.

Infliximab. The studies also found comparable efficacy for biosimilars treating both cutaneous and articular disease, whether the patients were switching from the originator to a biosimilar or between biosimilars. Only 1 study showed an increase in the number of mild AEs, but the authors noted there was no statistical analysis performed in the study.

Overall, the researchers found the “real-world evidence is consistent with controlled trials and may be reassuring to patients and providers.” Lack of confidence in biosimilars from both physicians and patients has been one barrier to the uptake of biosimilars, and both groups have reported they prefer the reference product over biosimilars.

While better education for both physicians and patients on the real-world findings of biosimilar switching could improve biosimilar use, the author noted that any loss of efficacy or appearance of an AE will likely be blamed on the switch, even if the switch did not cause the issue.

Some of the limitations of the studies included in this review were the sample sizes, duration of follow-up, and study design (ie, single-arm studies without control groups).

“Understanding that biologics cannot be duplicated (not even from batch to batch of the innovator) makes clear that patients are already switching from one biologic to another, even when they think they are taking the same product,” the authors concluded. “Doing so appears to be safe and effective, and the available real-world evidence suggests that patients can also safely and effectively undergo (non-medical) switching to biosimilar therapies for the treatment of psoriasis.”

Reference

Ruda RC, Kelly KA, Feldman SR. Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis. J Dermatolog Treat. Published online October 28, 2022. doi:10.1080/09546634.2022.2140569