Biosimilars
OVERVIEW OF BIOSIMILARS
The psoriasis treatment paradigm includes biosimilars into the biologics category of effective and safe systemic therapies. A biosimilar is highly similar to its reference biologic and has no clinically meaningful differences in efficacy, safety, or immunogenicity to the reference product. Approval of biosimilars must meet the rigorous standards of regulatory guidance. Biomimic products, however, are not included in the category of biosimilars since they have not demonstrated bioequivalence to their reference product through a stringent approval pathway.
IPC’s biosimilars initiative focuses on educating healthcare practitioners around the globe on the similarities and differences between reference biologics, biosimilars and biomimics. Dermatologists require the most current information in this rapidly evolving field in order to better understand the benefits and risks of biosimilar products and ultimately integrate their use into practice to improve patient outcomes.
The resources provided here offer background information on biosimilars, suggest practical guidance on communicating biosimilar benefits to patients, and present real-world clinical scenarios of psoriasis management with biosimilars.
Fast Facts
- Biosimilars are rigorously evaluated to ensure they match their reference biologics in safety, efficacy, and quality.
- Unlike biomimics, biosimilars must demonstrate bioequivalence through strict regulatory pathways.
- Adopting biosimilars in psoriasis care can expand treatment access, especially in resource-limited settings.
- Dermatologists should stay informed on biosimilar approval, interchangeability, and patient communication as the treatment landscape evolves.
Latest Publications
IPC Resources
PUBLICATIONS AND RESEARCH
The IPC Biosimilars Working Group (2014 – 2020) has examined biosimilar issues such as extrapolation, interchangeability, automatic substitution in the clinical setting, and pharmacovigilance. The following publications are a product of this work.
Additional Resources
Below are resources from other organizations that discuss the use of biosimilars for the treatment of psoriasis.
PUBLICATIONS AND RESEARCH
The Role of Biosimilars in Enhancing Global Access to Psoriasis Treatment. Behlock Y, Gavan SP, Graier T, et al. J Invest Dermatol. 2026. doi: 10.1016/j.jid.2026.01.047.
Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review. Wiland P, Both C, Gaylis NB, et al. Adv Ther. 2025 Mar;42(3):1360-1392. doi: 10.1007/s12325-024-03098-z. Epub 2025 Feb 5. Erratum in: Adv Ther. 2025 Jun;42(6):2970-2971. doi: 10.1007/s12325-025-03181-z. PMID: 39907897; PMCID: PMC11949999.
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. Sagi S, Anjaneya P, Kalsekar S, Kottke A, Cohen HP. Drug Saf. 2023 Dec;46(12):1391-1404. doi: 10.1007/s40264-023-01371-8. Epub 2023 Oct 30. PMID: 37902937; PMCID: PMC10684613.
WEBSITES
Biosimilars in the United States
U.S Food & Drug Administration
Biosimilars in Europe
European Medicines Agency
AJMC: The Center For Biosimilars
Countries with guidelines for biosimilars
Generic & Biosimilars Initiative (GaBI)
Page last updated: May 2025