This year, many new labels will come to market for the treatment of psoriasis, including Amjevita, the first biosimilar in the United States for adalimumab. Though this biosimilar was first approved by the U.S. Food and Drug Administration (FDA) in 2016, it was made commercially available to patients on January 31, 2023. There will likely be several other biosimilars that will become available later in 2023.  As these biosimilars enter the market, they may change the current health care marketplace in ways we cannot currently predict.
Biologics and Biosimilars
“To understand biosimilars, you first have to understand biologics,” says Steven R. Feldman, M.D., Ph.D., a dermatologist, dermatopathologist, and professor at Wake Forest University School of Medicine. Various biologics have been used to treat psoriasis and have seen increasing use since they first came to market. Biologic drugs are, in essence, large and complex proteins; the biologics used for psoriasis are antibodies that function to block certain steps of immune pathways that are associated with the inflammation seen in psoriatic disease. For instance, adalimumab inhibits the molecule tumor necrosis factor-alpha, a cytokine that regulates and induces subsequent inflammation. However, because the manufacturing process to create biologic molecules is so complicated, biologics cannot be duplicated, even by the innovator company itself.  As such, even within innovator products, there is batch-to-batch variation.
Biosimilars are drugs that are highly similar to their originator products, having the same amino acid structure as the originator. However, the biosimilar is not an exact duplicate given the complexity of various other parts of protein processing during production. Nevertheless, biosimilars are expected to perform similarly to batches of their originator product, as they bind the same drug target and have similar pharmacokinetics to the originator product. To substantiate this, clinical trials are done to confirm that clinical efficacy is similar.  Studies in patient registries and clinical trials have shown similar efficacy for biosimilars for drugs such as infliximab and adalimumab when compared to their originator products.