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    Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right
    Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right
    Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right
    Ebook210 pages1 hour

    Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right

    By Paul Cornes and Ali McBride

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    About this ebook

    Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients.
    LanguageEnglish
    PublisherS. Karger
    Release dateJan 24, 2020
    ISBN9781912776221
    Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right

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      Book preview

      Fast Facts - Paul Cornes

      Introduction

      Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The first biologics have now reached patent expiry and lower-cost versions – biosimilar medicines – have been developed (Table 1). The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days’ exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. In comparison, the US market is still naive to biosimilar entry; biosimilars have only been introduced since the approval of the Affordable Care Act 2010, and – at the time of writing – only 23 biosimilars have been approved, although there are more than 60 biosimilars in development.

      The rationale for biosimilar medicines is economic; the high costs of biological medicine threaten the sustainability of healthcare in even the wealthiest of nations. Despite making up only a small proportion of medicine prescriptions by volume, their costs have surged to between 25% and 50% of total medicines spending in many nations. This trend particularly threatens cancer treatment; most cancer drugs launched since 2009 were biologics and were priced at more than $100 000 per patient for 1 year of treatment.¹ The World Innovation Summit for Health (WISH) Forum stated: We must confront a stark reality: cancer care is not affordable for most patients, many payers, and nearly all governments. This is a real and immediate issue across the world.²

      Once patents have expired, follow-on versions of high-cost medicines could act as a brake on growth. Between 2018 and 2024, US$251 billion of current patent-protected sales could be replaced by cheaper versions.³ The potential cost-savings delivered by competition between brands has the potential to increase patient access to effective treatments.

      However, concerns persist about biosimilars, particularly in curative cancer treatment where biosimilars are relatively recent additions to the formulary. Furthermore, anti-cancer biologics are frequently used in combination with cytotoxic chemotherapy, making the assessment of biosimilar medicines in isolation a technical challenge for developers and regulators. Unlike the first generation of growth factor biosimilars, which have one mode of action and one target receptor as well as an easily assessed biological readout, cancer therapeutics are typically monoclonal antibodies with multiple potential modes of action and therapeutic targets. Adding to this concern is the knowledge that failure of first-line cancer treatment usually signals a failure to cure a patient. For this reason, oncologists and hematologists use their most effective therapy first; a stark contrast to, say, the treatment of inflammatory disease, where biologic targeted therapy is used only after the failure of often several lines of treatment with simpler chemical drugs such as steroids or methotrexate.

      TABLE 1

      Reference biological medicines

      CD, cluster of differentiation; FSH, follicle-stimulating hormone; HER2, human epidermal growth factor receptor 2; INN, international non-proprietary name; TNF, tumor necrosis factor; VEGF, vascular endothelial growth factor.

      It is for these reasons that we have written Fast Facts: Biosimilars in Hematology and Oncology. It addresses these concerns, drawing on the most up-to-date information in this fast-moving area of medicine.

      •Is the quality of the biosimilar medicine equivalent to that of the original drug?

      •Is the biosimilar medicine safe?

      •Which indications can the biosimilar medicine be used for?

      •What are the

      realistic economic benefits?

      •How do I switch a patient from a biologic to an equivalent biosimilar medicine?

      •How do I explain biosimilars to patients, relatives and fellow healthcare professionals?

      The answers are supported with a concise explanation of the underlying science and regulatory principles, drawing on the significant experience accumulated within Europe, together with emerging global practice.

      This concise authoritative resource will help clinicians and other healthcare decision makers to determine the value of biosimilars in clinical practice and aid discussions with patients.

      References

      1. Rimer BK. The imperative of addressing cancer drug costs and value. NIH National Cancer Institute, 2018. www.cancer.gov/news-events/cancer-currents-blog/2018/presidents-cancer-panel-drug-prices, last accessed 6 May 2019.

      2. Thomas RJS, Callahan R, Bartlett R, J Geissler. Delivering affordable cancer care: a value challenge to health systems. Wish Cancer Forum, 2015. www.wish.org.qa/wp-content/uploads/2018/01/WISH_Cancer_Forum_08.01.15_WEB.pdf, last accessed 17 October 2016.

      3. Anonymous. EvaluatePharma world preview 2018, outlook to 2024. Evaluate, 2018. www.evaluate.com/thought-leadership/pharma/evaluatepharma-world-preview-2018-outlook-2024. last accessed 13 June 2018.

      Biological medicines (biologics) are drugs derived or extracted from living systems, usually modified bacteria, fungi or animal cells; the three main categories are listed in Table 1.1. Biologics have been able to transform the outcomes of many previously hard-to-treat diseases, becoming an essential component in the treatment of diseases including diabetes, anemia, rheumatoid arthritis and cancer. This is reflected in the inclusion of biologics in the WHO list of essential medicines. These ‘essential medicines’ are those the WHO believes should be provided free, or at prices all citizens can afford; but this creates a problem. Biologics are inherently more expensive than past-generation medicines; they represent the result of costly investment in research and development and are manufactured using cellular-based technologies and utilizing gene expression. The combination of medical benefit but high costs for biologics creates the need for biosimilars.

      TABLE 1.1

      Three main categories of biologics (many with importance in hematology and oncology)

      Costs and economics

      The transition from the era of small molecule drugs to that of the biologics has markedly increased drug expenditure – and especially so for cancer. For example, 8 weeks of standard chemotherapy for advanced colorectal cancer cost US$63 in the small molecule era but $30 790 using biologics, representing an almost 500-fold increase in drug costs – although this has been accompanied by improved outcomes.¹ The high prices of biologics are justified by manufacturers on the basis of the investment in discovery, development and production.

      Biological agents represent the largest growth in pharmaceutical innovation, with new agents submitted for approval annually. In 2017, for example, more than 200 molecules were in late-stage development for cancer and hematologic malignancies – up over 60% from a decade ago. Almost 90% of those therapies in development were targeted biological treatments.²

      The current cost of biologics is rising quickly – threatening the sustainability of healthcare.³ So significant is this threat to delivering global cancer treatment that the WHO 70th World Health Assembly of 2017 established a Technical Working Party to report on the impact of drug pricing in cancer.⁴ The WHO report noted that, in relative terms, prices and costs of cancer medicines are higher than the prices and costs of medicines used in other therapeutic areas; over 1997–2016, the median annual cost of monoclonal antibodies was significantly higher when used in oncology and hematology (US$142 833) compared with the next highest-priced therapeutic categories: immunology (US$53 969); infectious disease; and allergy.

      The result has been problems with access to innovative medicines. Access to biological drugs, whether anti-inflammatory or cancer, is strongly associated with national wealth.⁵,6

      There is a consensus on solutions; health systems need to maximize the use of competition between manufacturers to check prices. For this to work, nations need to encourage the early launch and swift uptake of competitor medicines once patents have expired.⁷ For conventional synthetic small molecule medicines, these competing brands are called generic medicines, while the follow-on versions of biologics are termed biosimilar medicines (in countries including Europe, USA and Japan) – see Table 1.2 for definitions.

      TABLE 1.2

      Key definitions: generics and biosimilars

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