Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review

ABSTRACT

Introduction: Many tumor necrosis factor (TNF)-alpha ‘biosimilar’ agents have been approved for the treatment of psoriasis and other autoinflammatory conditions. These biosimilars have the same structure as the originator biologic and have been shown to be equivalent in terms of safety and efficacy. However, given the method by which biosimilars are manufactured, they are not exact replicas of the originator, unlike generic forms of non-biologic medications. Therefore, there is controversy regarding whether these agents should be considered interchangeable with their originator biologics.

Areas covered: The objective of this review is to summarize the safety data for each of the approved TNF-alpha biosimilars to determine whether or not these agents have appropriate safety profiles to replace their originator biologics.

Expert opinion: Based on extrapolation of phase III investigations in patients with rheumatologic diseases, each of the approved anti-TNF agents have comparable efficacy, tolerability, and safety profiles to their originators. Studies in patients with psoriasis are more limited. Transitioning from a biologic to its biosimilar has also been shown to be similarly safe and immunogenetic compared to maintenance therapy with the originator. More post-marketing studies are needed to demonstrate the long-term safety in patients with psoriasis.

KEYWORDS:

• Adalimumab
• biologic
• biosimilar
• etanercept
• infliximab
• psoriasis
• safety
• treatment
• tumor necrosis factor inhibitor

Article Highlights

• Tumor necrosis factor (TNF)-alpha ‘biosimilar’ agents of adalimumab (Amjevita/Amgevita/Solymbic, Cyltezo, Imraldi/Hadlima, Hyrimoz/Hefiya/Halimatoz), etanercept (Erelzi, Benepali/Eticovo), and infliximab (Inflectra/Remsima, Renflexis/Flixabi, Ixifi/Zessly) have been approved for the treatment of psoriasis.

• Phase III investigations in patients with rheumatologic diseases have shown that each of the approved anti-TNF agents have comparable efficacy, tolerability, and safety profiles to their originators, although studies in patients with psoriasis are limited.

• Switching from a biologic to its biosimilar has also been shown to be similarly safe and immunogenetic compared to maintenance therapy with the originator biologic.

• Biosimilars seem to be a safe and effective alternative to originator biologics, and since they have a less costly development process, they may increase the accessibility of biologics worldwide.

• More post-marketing studies are needed to demonstrate the long-term safety and efficacy of biosimilars in the treatment of psoriasis.

This box summarizes key points contained in the article.

Declaration of Interest

JJ Wu is or has been an investigator for AbbVie, Amgen, Eli Lilly, Janssen, Novartis; a consultant for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Promius Pharma, Regeneron, Sun Pharmaceutical, and UCB, Valeant Pharmaceuticals North America LLC; and a speaker for AbbVie, Amgen, Celgene, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America LLC. G Han is or has been an investigator for Athenex, Boehringer Ingelheim, Bond Avillion, Bristol-Myers Squibb, Celgene, Eli Lilly, Novartis, Janssen, MC2, PellePharm, Pfizer, and UCB; and a consultant, advisor, or speaker for Abbvie, Eli Lilly, Janssen, LEO Pharma, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, SUN Pharmaceutical, and UCB. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Notes

1. Treatment emergent adverse events reported in both biosimilar and biologic treatment groups, with comparable incidence rates to those observed in biosimilar pivotal trials.

Additional information

Funding

This paper was not funded.