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Rows of drug vials in a production line.
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The significance for providers and people with psoriasis or PsA.

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. [1] 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. [2] 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. [2] 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. [3][4]

Marketplace Responses

Biologics are extremely expensive and have increased in cost since they first came to market. [5] Because of the cost, many patients use copay assistance to afford their treatment. Competition from biosimilars is theoretically thought to be able to help lower costs of treatment and free up resources within the health care system to improve access. [6] However, Dr. Feldman feels that the changes brought about by biosimilars may be hard to predict. “I don’t think this is going to help psoriasis patients a lot, because the reduction in cost is not likely to be large enough to improve drug access,” Feldman says.

While there are a variety of biologics that have biosimilars in the pipeline, there are also many biologics that do not have biosimilars currently under investigation. Policy changes may limit access to other non-biosimilar treatments. For instance, Feldman mentions that insurers may change reimbursement guidelines to encourage use of lower-cost biosimilars over innovator drugs that do not yet have biosimilars. “Because biosimilars function so similar to the innovator product, we won’t be able to help psoriasis patients with biosimilars unless we could help them already with the innovator,” Feldman says.

Overall, Dr. Feldman foresees a decrease in prices of biologics that face biosimilar competition by around 30% in the first few years. However, changes in price do not equal changes in access, and Dr. Feldman feels that changes to access will be hard to predict. “Overall, I don’t think there’s going to be much change in access at all,” Dr. Feldman says. In the European Union, biosimilar access was limited by responses by the innovator companies, relatively small price savings, and reluctance of physicians to use biosimilars. [6]

Patient Responses

As more biosimilars are approved in the U.S. and patients learn about biosimilars through media coverage and advertisements, Dr. Feldman thinks that some patients may have hesitations regarding taking biosimilars. “I know physicians who were very hesitant with the idea of biosimilars, too,” Dr. Feldman says, as biologic manufacturing is complicated and physicians may think that biosimilars may not perform the same as the innovator biologic.

“However, once patients and doctors realize that no one can duplicate a biologic, not even the innovator company, I think they will be more accepting of biosimilars that are basically – for all practical purposes – just like another batch of the innovator,” Dr. Feldman says.

He adds that he thinks patients will have to be counseled on an individual basis. Some may benefit from an explanation about what biosimilars are and whether they are effective; others may need more specific information explaining the manufacturing process and the similarities and differences between biosimilars and their innovator biologics.

Despite challenges and unknowns, the future shows promise for more biosimilars. Biosimilars of infliximab in the U.S. already exist, while ustekinumab biosimilars are currently under investigation. And despite the unpredictable responses of the marketplace, many are optimistic about biosimilars and how they will affect patient care. [7]

Latest News About Biosimilars

Hear the latest news from Julie Reed, Executive Director with the Biosimilars Forum on this sponsored episode of the Psound Bytes™ podcast.

Listen now

Sonia Wang


Medical student at the University of Pennsylvania School of Medicine


1. Jeremias, S. US Welcomes First Adalimumab Biosimilar, Amjevita. 2023. Accessed Feb 15, 2023.

2. Barker J, Girolomoni G, Egeberg A, Goncalves J, Pieper B, Kang T. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. 2020;31(8):794-800. doi:10.1080/09546634.2019.1610553

3. Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.Br J Dermatol. 2020;182(2):316-326. doi:10.1111/bjd.18220

4. Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis.Br J Dermatol. 2018;178(2):509-519. doi:10.1111/bjd.16102

5. Cheng J, Feldman SR. The cost of biologics for psoriasis is increasing. Drugs Context. 2014;3:212266. Published 2014 Dec 17. doi:10.7573/dic.212266

6. Blackstone EA, Joseph PF. The economics of biosimilars.Am Health Drug Benefits. 2013;6(8):469-478. PMCID: PMC4031732.

7. Baumgart DC, Misery L, Naeyaert S, Taylor PC. Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?.Front Pharmacol. 2019;10:279. Published 2019 Mar 28. doi:10.3389/fphar.2019.00279

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