Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA

Introduction: Healthcare providers often lack familiarity with the concepts surrounding the biosimilars industry and the evidence required to support biosimilar development. This paper assesses current understanding, knowledge and perception of biosimilars in different specialties, with the aim of encouraging greater uptake.
Methods: The authors assess factors that may impede the acceptance of biosimilars in the medical community and explore measures to enhance confidence. This was achieved with a search of the published literature and preliminary results of an online survey conducted by the authors amongst physicians across different specialities.
Results: Even in established biosimilar markets, understanding of biosimilar-specific terms such as switching and extrapolation is variable and knowledge of evidence required for biosimilar development and approval is lacking and/or outdated. Lack of familiarity with these concepts and the evidence required to support biosimilar development may deter healthcare providers from using biosimilars to their full advantage. More education for healthcare professionals is required in therapeutic areas where biosimilars are prescribed, and this should be updated regularly in step with evolving regulations.
Conclusion: The successful adoption of biosimilars worldwide will require the continuing education of all healthcare professionals and stakeholders. This should include information on totality of evidence and data required for regulatory approval pathways, as well as clinically relevant concepts and terms. Lessons learned in established biosimilar markets and disease areas, such as oncology and immunology/rheumatology, can shared with other countries and across different therapeutic areas to help prepare the market for new biosimilar entrants.

Submitted: 2 May 2023; Revised: 14 January 2024; Accepted: 14 January 2024; Published online first: 26 January 2024

Introduction

Biological therapies have revolutionized care for many patients with chronic conditions, including cancers [1]. However, as the largest driver of rising prices for therapeutic agents [2], they put a financial strain on healthcare systems, limiting patients’ access to required medication [3]. With the expiration of patents for biological medicines, the opportunity to develop and market biosimilar medications arises, promising to make the treatment benefits of biological drugs more accessible. While the cost of developing and manufacturing biosimilars remains high compared with generics, they still offer savings to healthcare systems by delivering the same quality, efficacy, and safety. According to a recent report from the Association for Accessible Medicine, the biosimilar sale price was, on average, 50% less than the reference brand biological price [4]. Furthermore, competition from biosimilars has reduced the sales price of their corresponding reference biological by an average of 25%. Biosimilars bear no significant clinical differences from their reference medicinal product and face rigorous approval pathways. Although biosimilar manufacturing and its corresponding regulations have become more established, resulting in an increased number of approvals, healthcare providers and patients might often lack confidence in their use, despite the potential for reducing treatment costs and improving patient access. In this opinion paper, the authors assess factors that may impede the acceptance of biosimilars in the medical community and explore measures to enhance confidence.

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