Navigating adalimumab biosimilars: an expert opinion

Author:

Abitbol Vered1,Benkhalifa Salim2,Habauzit Caroline2,Marotte Hubert3ORCID

Affiliation:

1. Service de gastroentérologie, Hôpital Cochin, AP-HP, Université Paris Cité, Paris, 75014, France

2. Celltrion Healthcare SAS, Issy Les Moulineaux, 92130, France

3. Université Jean Monnet Saint-Étienne, CHU Saint-Étienne, Service de Rhumatologie, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, 42023, France

Abstract

The patent expiry of Humira ® in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita ® , Amsparity ® , Hulio ® , Hukyndra ® , Hyrimoz ® , Idacio ® , Imraldi ®  and Yuflyma ® – for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima ® , Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.

Publisher

Becaris Publishing Limited

Subject

Health Policy

Reference73 articles.

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3. Electronic Medicines Compendium. Humira 40mg/0.4ml solution (2021). https://www.medicines.org.uk/emc/product/2150/smpc

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5. US Food and Drug Administration. Purple book database of licensed biological products. USFDA MD USA (2021). https://purplebooksearch.fda.gov

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