New Review of Biosimilars in Oncology
LONDON, June 23, 2016 /PRNewswire/ --
Andrew D Zelenetz, Oncology & Hematology Review, 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22
Published recently in Oncology & Hematology Review, the peer-reviewed journal from touchONCOLOGY, Andrew D Zelenetz, discusses the fact that the escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies. With the patents on many biologics expiring, interest in biosimilars is rising. Biosimilars of biologic agents used for cancer treatment and supportive care are making their appearance in the US; this article therefore aims to increase understanding of the biosimilars concept. Biosimilars are very comparable to their reference products, but because of their size and complexity, are not identical. However, the inherent structural differences between biologics and their reference products may not translate to clinically meaningful differences in efficacy and safety. Biosimilars offer potential cost savings but present a challenge in terms of establishing a regulatory pathway. Regulatory approval requires comparative analytical and clinical studies in order to characterize and demonstrate the absence of clinically meaningful differences between biosimilars and their reference products. Initial approval may not include interchangeability, as additional evidence may be required before a biosimilar can be designated interchangeable with its reference product. A framework for the approval of biosimilars was established by the European Medicines Agency (EMA) in 2006 with the first biosimilar approved in April, 2006. Thus, the experience in Europe provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving patient access without compromising patient outcomes, but clinician education and acceptance is crucial.
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The full peer-reviewed, open-access article is available here:
Andrew D Zelenetz has received research support from Genentech/Roche, MEI Pharmaceuticals, BeiGene, BMS, Gilead, and Mirati Pharmaceuticals, and participated in advisory boards/consultancy for Genentech/Roche, Gilead, Celgene, Adaptive Biotechnology, Hospira, and Novartis.
About touchONCOLOGY.com: touchONCOLOGY (a division of Touch Medical Media) publishesOncology & Hematology Review, a peer-reviewed, open access, bi-annual journal specialising in the publication of balanced and comprehensive review articles written by leading authorities to address the most important and salient developments in the field of oncology and hematology. The aim of these reviews is to break down the high science from 'data-rich' primary papers and provide practical advice and opinion on how this information can help physicians in the day to day clinical setting. Practice guidelines, symposium write-ups, case reports, and original research articles are also featured to promote discussion and learning amongst physicians, clinicians, researchers and related healthcare professionals.
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