International Psoriasis Council

Advancing Knowledge. Enhancing Care.

Advancing Knowledge. Enhancing Care.

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 2019 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.

IPC Resources

PUBLICATIONS AND RESEARCH

IPC Biosimilars Working Group 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.

BIOSIMILARS FOR THE TREATMENT OF PATIENTS WITH PSORIASIS: A CONSENSUS STATEMENT FROM THE BIOSIMILAR WORKING GROUP OF THE INTERNATIONAL PSORIASIS COUNCIL

Arnon D. Cohen, Ronald Vender, Luigi Naldi, Robert E. Kalb, Tiago Torres, Murlidhar Rajagopalan, Joelle van der Walt, Lluís Puig, Helen S. Young. JAAD International. 2020 Sept 25. doi: 10.1016/j.jdin.2020.09.006.

BIOSIMILARS FOR PSORIASIS—EXPERIENCE FROM EUROPE

Arnon D. Cohen, Tiago Torres, Wolf-Henning Boehncke, Menno de Rie, Denis Jullien, Luigi Naldi, Caitriona Ryan, Robert Strohal, Lone Skov, Peter van de Kerkhof, Joelle M. van der Walt, Jashin J. Wu, Claus Zachariae, Lluis Puig, Helen Young. Current Dermatology Reports (2019) 8:26–34.

BIOSIMILARS FOR PSORIASIS: WORLDWIDE OVERVIEW OF REGULATORY GUIDELINES, UPTAKE AND IMPLICATIONS FOR DERMATOLOGY CLINICAL PRACTICE.

Cohen AD, Wu JJ, Puig L, Chimenti S, Vender R, Rajagopalan M, Romiti R, de la Cruz C, Skov L, Zachariae C, Young HS, Foley P, van der Walt JM, Naldi L, Prens EP, Blauvelt A. Br J Dermatol. 2017 Dec;177(6):1495-1502. doi: 10.1111/bjd.15756. 28646580, Epub 2017 Nov 27.

BIOSIMILARS IN PSORIASIS: CLINICAL STUDIES TO DETERMINE SIMILARITY.

Blauvelt A, Puig L, Chimenti S, Vender R, Rajagopalan M, Romiti R, Skov L, Zachariae C, Young H, Prens E, Cohen A, van der Walt J, Wu JJ. Br J Dermatol. 2017 Jul;177(1):23-33. doi: 10.1111/bjd.15067. Epub 2017 May 28

BIOSIMILARS IN PSORIASIS: CLINICAL PRACTICE AND REGULATORY PERSPECTIVES IN LATIN AMERICA.

de la Cruz C, de Carvalho AV, Dorantes GL, Londoño Garcia AM, Gonzalez C, Maskin M, Podoswa N, Redfern JS, Valenzuela F, van der Walt J, Romiti R. J Dermatol. 2017 Jan;44(1):3-12. doi: 10.1111/1346-8138.13512. 27461455, Epub 2016 Jul 27.

BIOSIMILARS FOR PSORIASIS: PRE-CLINICAL ANALYTIC ASSESSMENT TO DETERMINE SIMILARITY.

Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ; Br J Dermatol. 2016 Feb;174(2):282-6. doi: 10.1111/bjd.14267.

BIOPHARMACEUTICALS AND BIOSIMILARS IN PSORIASIS: WHAT THE DERMATOLOGIST NEEDS TO KNOW

VIDEOS

Biosimilars in Ten minutes: What You Need to Know

Tiago Torres, MD, PhD | Portugal
April 2021
[10:05 min]

Biosimilars: Part I

Colby Evans, MD | United States
April 2021
[4:43 min]

Biosimilars: Part II

Colby Evans, MD | United States
April 2021
[10:26 min]

What is a Biosimilar?

Mahira El Sayed, MSc, MD | Egypt
April 2021
[9:45 min]

No results found.

Additional Resources

Below are links to trusted resources on biosimilars. While not specific to dermatology, these resources can help increase your knowledge of how biosimilars are developed, approved, and used.              

WEBSITES

Biosimilars in the United States
U.S Food & Drug Administration
Biosimilars in Europe
European Medicines Agency
Countries with guidelines for biosimilars
Generic & Biosimilars Initiative (GaBI)