Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high price level of biosimilars. The quality, safety, and efficacy of biosimilars developed, according to the current guidelines of ‘stringent’ regulatory agencies have proven to be […]

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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 […]

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