The Biosimilar Revolution: A Look at the Potential Impact

When a groundbreaking drug becomes established on the market, a generic version typically follows. For biologic drugs, versions deemed to have no clinically meaningful differences from the reference product are referred to as biosimilars.¹ The first biosimilars are already on the market. In the United States, a new drug patent is granted for 20 years from the date the application is filed, though various circumstances allow for extensions.² For example, biosimilars for adalimumab (Table 1) became available in 2023—39 years after the initial patent and 21 years after US Food and Drug Administration (FDA) approval.³ Patents for dupilumab and secukinumab are expected to expire in 2027 and 2029, respectively.⁴

Although biosimilars must undergo their own clinical trials and gain FDA approval, testing may begin before the reference product’s patent expires. The median time from phase 1 initiation to approval for the first 20 approved biosimilars across medicine was 69.9 months.⁵

From 2015 through late March 2025, the FDA approved a total of 73 biosimilars; 19 of those approvals occurred in 2024—nearly double that of any previous year—and 9 were approved in the first quarter of 2025 (Table 2).⁶ In dermatology, biosimilars are available not only for adalimumab but also for ustekinumab, infliximab, rituximab, etanercept, and omalizumab.⁶

While the cost savings of biosimilars are often highlighted, many dermatologists remain hesitant to use those currently available. In a Journal of Drugs in Dermatology survey conducted in 2024, 61% of respondents expressed concerns regarding the safety and efficacy of biosimilars, only 35% reported feeling moderately or extremely knowledgeable about biosimilar interchangeability, and 20% indicated they would not prescribe a biosimilar for an FDA-approved indication.¹ Not all biosimilars are considered interchangeable—that is, approved for substitution without prescriber involvement—and substitution laws vary by state. However, the FDA asserts that “patients and health care providers can be as confident in the safety and effectiveness of the biosimilar and interchangeable biosimilar as they can be for the reference product.”⁴ These products may be used in both treatment-naïve patients and those previously treated with the reference product.⁷

With many more biosimilars expected to gain approval, Practical Dermatology interviewed Collin Blattner, DO, FAAD—an editorial board member and double-board–certified dermatologist who owns Clearchoice Dermatology, which has 12 locations in Oregon and Washington—about the potential impact.

TABLE 1: BIOSIMILARS FOR ADALIMUMAB⁶

FDA-approved biosimilars for the drug first offered by AbbVie under the trade name Humira

Are we experiencing, or do you expect soon, a biosimilar revolution in dermatology?

There are more biosimilars on the market than ever before. In my practice, I am seeing approximately 5% to 10% of prescriptions being switched from trade medications to biosimilars. We are starting to see that shift. However, it has not reached 50% of patients, as the cost of biosimilars is not substantially lower than that of trade medications at this point. Some patients are being switched from a trade product to a biosimilar, which has caused some clinicians to hesitate. As clinicians become more informed about biosimilars, I believe they will become more comfortable using them.

When you refer to prescriptions being switched, is that just between the patient and the pharmacist, or is that a conversation between the clinician and patient as well?

It appears to be between the patient and the pharmacist. The clinician’s involvement typically ends once the prescription is written. I have simply noticed that some patients who were initiated on a trade medication ended up receiving a biosimilar.

Have you had any issues when your patients have switched?

A few patients have asked me what a biosimilar is. I explain that it is a very similar prescription and describe it as the generic equivalent of a biologic.

Do you need to be keeping up with the clinical trials for the dozens of biosimilars out there?

I do not think it is necessary to be familiar with every clinical trial for each biosimilar. Biosimilar trials are generally much smaller than the original FDA clinical trials, which include phases 1 through 4. As long as biosimilars demonstrate equivalence, they are considered safe and effective.

Do you consider the manufacturer?

Most of the major pharmaceutical companies are reputable and are typically the ones developing biosimilars, particularly as the patent life expires on some of their blockbuster drugs.

TABLE 2: FDA BIOSIMILAR APPROVAL VOLUME BY YEAR⁶

If cost remains a minimal factor, why do you recommend the trade option to patients?

The clinical trials for the original trademarked medications are more comprehensive, encompassing phases 1 through 4. These drugs are supported by a substantial amount of data, whereas biosimilars do not ye t have that volume of evidence. Therefore, I prefer that patients receive the medication I prescribe, not a biosimilar. However, I do recognize the financial burden on the health care system and understand that insurers and pharmacy benefit managers aim to reduce costs while providing similar therapies.

If the cost gap increases dramatically, can you ever envision a situation where you might suggest biosimilar options to a patient who has limited finances and/or coverage?

That is likely the direction things are heading. However, biosimilars would need to be significantly more affordable than trade medications for that to be a compelling choice. A 5% price difference is not motivating. A 55% difference? That would be a substantial, motivating cost savings.

Are there any disease states for which it would be particularly helpful to have a dramatically lower-cost option?

All of them. Many patients have psoriasis, atopic dermatitis, and hidradenitis suppurativa—more than we previously realized. Patients with alopecia areata would also benefit from a lower-cost option, especially given that some insurers classify it as a cosmetic condition rather than a medical one.

Would you be hesitant to prescribe a biosimilar off-label for something like alopecia areata?

No. Dermatologists are familiar with prescribing medications off-label. If a biosimilar is truly comparable and a patient can access it—even off-label—I would not be concerned.

Which drugs are you most interested to see biosimilars for in the future?

A key question is whether biosimilars will emerge for small molecules. For example, apremilast comes off patent in 2028. Will a biosimilar be developed for it? Otezla still holds a third of the naive market for psoriasis. Although it is an older drug, a biosimilar could be very impactful. What would a biosimilar look like for a small-molecule pill? That remains unclear.

Back to our first question, what needs to happen for this to truly be a biosimilar revolution?

Awareness is key. People need to know biosimilars are on the market and that they are highly similar in clinical efficacy. As more drugs lose patent protection, the number of biosimilars will likely continue to grow—that will be a major driver of this shift. n

1. Zameza PA, Kontzias C, Flanders K, Sonnenreich P, Feldman SR. Dermatologists’ perspectives on biosimilars. J Drugs Dermatol. 2024;23(4):277-280. doi:10.36849/JDD.7755

2. US Food and Drug Administration. Frequently asked questions on patents and exclusivity. Updated February 5, 2020. Accessed April 7, 2025. https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity

3. Initiative for Medicines, Access, and Knowledge. Humira’s patent wall. Accessed April 7, 2025. https://www.i-mak.org/wp-content/uploads/2020/12/Humira-deck-2020-10-22.pdf

4. Siddiqui A. Mitigating patent cliff fallout. BioSpectrum Asia. Published March 1, 2025. Accessed April 7, 2025. https://www.biospectrumasia.com/analysis/25/25658/mitigating-patent-cliff-fallout.html

5. Lee CC, Kesselheim AS, Sarpatwari A. Clinical development times for biosimilars in the United States. Mayo Clin Proc. 2020;95(10):2152-2154. doi:10.1016/j.mayocp.2020.06.039

6. Stewart J. What biosimilars have been approved in the United States? Drugs.com. Updated March 26, 2025. Accessed April 3, 2025. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/

7. US Food and Drug Administration. Biosimilars info sheet. Accessed April 3, 2025. https://www.fda.gov/media/154917/download