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Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies

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Abstract

Background

Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence.

Objectives

The study aimed to describe and assess the recommendations of published position statements regarding several aspects of biosimilars across specialties and determine whether these positions have changed with the emergence of new evidence.

Methods

We systematically searched for published position statements of biosimilars in online databases and included statements written in English. The search was from the inception of the databases until May 2023. Two reviewers independently extracted the data. Only position statements that included recommendations to guide the use of biosimilars in clinical practice and were issued by health organisations and societies, including expert panels, were included. We synthesised recommendations on five aspects: prescribing practice, extrapolation of indication, interchangeability, treatment initiation with biosimilars in biologic-naïve patients, and pharmacovigilance.

Results

The review included 25 papers involving eight specialties, 16 of which were from European countries, 1 from an international organisation representing 49 countries, and 6 from various countries. The papers were published between 2009 and 2020, with 19 published between 2015 and 2020. Of the five aspects of biosimilars assessed, nearly half (11 of 25) of the papers at the time they were published did not base their positions on a scientific or evidence-based approach. Only 4 of the 25 position papers were identified as revisions of their previous papers. With increasing experience in biosimilars and the emergence of new evidence, about 60% (16 of 25) of the papers contained outdated recommendations, particularly on two aspects. They were extrapolations of indications and interchangeability (including switching). The recommendations for most papers for three other aspects were still appropriate. These were prescribing biosimilars by their brand name and active ingredient, initiating treatment with biosimilars in biologic-naïve patients, and monitoring the long-term safety of biosimilars through pharmacovigilance. For four of the revised papers, their position evolved from opposing indication extrapolation for biosimilars to accepting it, while the position of two papers shifted from not recommending biosimilar switching to permitting the practice. Meanwhile, most papers were against automatic substitution by pharmacists because the evidence for this practice was still limited.

Conclusions

Across specialties, the variability among the position statements is seen for extrapolation of indications for biosimilars and interchangeability (including switching). This requires a revision, considering the latest evidence and growing experience with the use of biosimilars in extrapolated indications and with switching.

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Acknowledgements

The authors would like to thank the Director-General of Health Malaysia for his permission to publish this article.

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Authors and Affiliations

  1. Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia

    Noraisyah Mohd Sani, Zoriah Aziz & Adeeba Kamarulzaman

  2. National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Petaling Jaya, Malaysia

    Noraisyah Mohd Sani

  3. Faculty of Pharmacy, MAHSA University, Jenjarom, Malaysia

    Zoriah Aziz

  4. Monash University Malaysia, Subang Jaya, Malaysia

    Adeeba Kamarulzaman

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The conceptualisation and design of this study were undertaken by NMS and ZA. The search was conducted by NMS. The screening process for document inclusion was conducted independently by NMS and ZA. The data were extracted by NMS, subsequently verified by ZA and subjected to a thorough review. The initial draft of the manuscript was prepared by NMS. ZA and AK conducted an extensive assessment of the manuscript with regards to its significant intellectual content. The draft of the manuscript underwent critical revisions by ZA. The final manuscript for publication was read and approved by all authors.

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Mohd Sani, N., Aziz, Z. & Kamarulzaman, A. Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies. BioDrugs (2024). https://doi.org/10.1007/s40259-024-00649-2

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