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

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 in different specialties, with the aim of encouraging greater uptake. Methods: The authors assess factors that may impede the acceptance of biosimilars in the medical community and explore measures to enhance confidence. This was achieved with a search of the published literature and preliminary results of an online survey conducted by the authors amongst physicians across different specialities. Results: Even in established biosimilar markets, understanding of biosimilar specific terms such as switching and extrapolation is variable and knowledge of evidence required for biosimilar development and approval is lacking and/or outdated. Lack of familiarity with these concepts and the evidence required to support biosimilar development may deter healthcare providers from using biosimilars to their full advantage. More education for healthcare professionals is required in therapeutic areas where biosimilars are prescribed, and this should be updated regularly in step with evolving regulations. Conclusion: The successful adoption of biosimilars worldwide will require the continuing education of all healthcare professionals and stakeholders. This should include information on totality of evidence and data required for regulatory approval pathways, as well as clinically relevant concepts and terms. Lessons learned in established biosimilar markets and disease areas, such as oncology and immunology/rheumatology, can be shared with other countries and across different therapeutic areas to help prepare the market for new biosimilar entrants.