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

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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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.