Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity with the concepts surrounding the biosimilars industry and the evidence required to support biosimilar development. This paper assesses current understanding, knowledge and perception of biosimilars […]


First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety […]