[HTML][HTML] The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019

HN Kang, R Thorpe, I Knezevic, CDRZ Blades… - Biologicals, 2020 - Elsevier
Abstract The World Health Assembly in 2014 adopted a resolution that mandates both
Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a
way that ensures their quality, safety and efficacy. The availability of biosimilars is expected
to increase access to biotherapeutic products by providing more treatment options triggering
competition which would lead to a consistent reduction in the average price of treatment.
Since the WHO guidelines for regulatory evaluation of biosimilars were issued in 2009 …
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