Biosimilars – status in July 2020 in 16 countries

Category: Original Research
Author(s): , , , , , , , , , , , , , , , , ,
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Keywords: approval, biosimilar, survey, WHO

Author byline as per print journal: Hye-Na Kang1, PhD; Robin Thorpe2, PhD; Ivana Knezevic1, PhD; Daehyun Baek3, PhD; Parichard Chirachanakul4; Hui Ming Chua5; Dina Dalili6, PhD; Freddie Foo7, MSc; Kai Gao8, PhD; Suna Habahbeh9, PhD; Hugo Hamel10, PhD; Edwin Nkansah11, PhD; Maria Savkina12, PhD; Oleh Semeniuk13; Shraddha Srivastava14; João Tavares Neto15, PhD; Meenu Wadhwa16, PhD; Teruhide Yamaguchi17, PhD

Abstract:
Development of biosimilars is important for healthcare as it allows the marketing of safe, efficacious and affordable biological products. The European Medicines Agency (EMA) was the first regulatory agency to establish a process for the approval of biosimilars and approved the first biosimilars in 2006.
Since then, there has been much progress in establishing the regulatory pathway for biosimilars and a wide range of biosimilars have been approved for marketing in many countries/geographical regions (1). An extensive number of biosimilars are now being used globally and are contributing considerably to widening patient access to appropriate biological medicines at reduced costs.
WHO has taken a lead in the biosimilar field at the global level and has developed specific guidance for biosimilar development and approval as well as a number of other pertinent guidelines (2-4). WHO has also organized a number of implementation workshops to assist regional regulatory agencies and manufacturers in the biosimilars area. As part of these workshops, surveys have been conducted to understand the current situation with biosimilars in the participants’ countries (1, 5, 6). These surveys provide a unique opportunity to establish the situation with currently marketed biosimilars in 16 countries. This publication presents this information.

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