Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases

ABSTRACT

Introduction: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naïve patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars.

Area covered: We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient–physician communication and need for shared decision-making.

Expert opinion: The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.

KEYWORDS:

• Biological therapy
• biosimilar
• immune-mediated inflammatory disease
• switching

Article highlights

• Switching patients from reference biologics to biosimilars may lead to significant cost savings, which can be used to increase access to biologics within the same budget constraints.

• Biosimilar development and approval are rigorous processes requiring demonstration of the biochemical and clinical equivalence of the biosimilar and reference product.

• Randomized controlled trials performed to date have demonstrated a lack of impact of switching from a reference product to a biosimilar on immunogenicity, safety, and efficacy.

• Emerging real-world evidence from registries, observational studies, and clinical experience is also supportive of switching to biosimilars and is complementary to clinical trials.

• Medical societies have expressed support for switching, conditional upon joint decision-making by patients and physicians.

• Ongoing real-world experience and patient education programs will play a role in ensuring successful switching from reference products to biosimilars.

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Acknowledgments

Fresenius Kabi SwissBioSim GmbH participated in the writing, review, and approval of the manuscript. All authors contributed to the development of the content; all authors and Fresenius Kabi reviewed and approved the manuscript; and the authors maintained control over the final content. Editorial and medical writing support was provided by Stephanie Carter, PhD, and Dan Hami, PhD, of Arc Medical Communications, Manchester, UK.

Declaration of interest

C Edwards has received honoraria for attendance at advisory boards for AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Fresenius Kabi, GlaxoSmithKline, Janssen, Lilly, Mundipharma, Roche, and Sanofi; and as a consultant for Anthera, Merck, and Samsung Bioepis; and has received grants as an investigator for AbbVie, Biogen, and Pfizer. J Hercogová has received honoraria for attendance at advisory boards for Novartis, Eli Lilly, Leo Pharma, Nordic Pharma, UCB, Sanofi Genzyme, and Fresenius Kabi; as an investigator for AbbVie, Merck, Amgen, Novartis, Eli Lilly, and Pfizer; and as a speaker for AbbVie, Biogen, Eli Lilly, Janssen-Cilag, Leo Pharma, L’Oréal, Nordic Pharma, Novartis, Pfizer, Sanofi Aventis, and Pierre Fabre. H Albrand is an employee of Fresenius Kabi SwissBioSim. A Amiot has received consulting fees from AbbVie, Hospira, Takeda, Gilead, and Biocodex; lecture fees and travel and accommodations from AbbVie, Janssen, Biocodex, Hospira, Ferring, Takeda, and Merck Sharp & Dohme; and advisory board fees from Gilead, Takeda, and AbbVie. 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 relationships or otherwise to disclose.

Additional information

Funding

This paper was sponsored by Fresenius Kabi SwissBioSim GmbH.