BACKGROUND AND OBJECTIVES: Biosimilar development is essential to expand access to quality-assured, safe, and effective biologic medicines.While the latter is a shared objective by healthcare systems across the globe, regulatorychallenges resulting from divergent regulatory requirements may complicate the biosimilar development pathway. This study aims (i) to identify the current regulatory and scientific challenges with regards to biosimilarity demonstration, (ii) to provide an updated and comprehensive overview of the evovling global regulatory lanscape of biosimilars, (iii) and to identify knowledge gaps in the literature. METHODS : Electronic databases (PubMed, Embase, Web of Science) and grey literature were searched up to January 2023. Identified records were categorized based on scientific and regulatory challenges related to biosimilarity demonstration. Additional categories were also identified during data extraction. RESULTS: The literature search yielded in total 2320 records of which 121 were selected after title and abstractscreening. A total of 63 articles were retrieved following the addition of other records through other sources as well (websites, organisations, snowballing). The present literature review has shown that up to date a large variability exists in regulatory requirements for the approval of biosimilars across the globe. Alongside divergent regulatory requirements, discrepancies were found in guideline interpretation among regulatory authorities, leading to unpredictability in the review process for the biosimilar sponsor. Key challenges identified in this literature review encompass the selection of the reference product, conducting analytical and/or PKPD bridging studies, in vivo animal studies, the significance of PD biomarkers, comparative clinical efficacy studies, and local clinical studies. Furthermore, the global regulatory landscape is further complicated by procedural challenges including lack of understanding in state-of-the-art analytical methods due to capacity and resource constraints, the absence of robust pharmacovigilance systems within some jurisdictions, and the absence of an insufficient framework for mutual recognition and regulatory reliance among jurisdictions. CONCLUSION: While biosimilar development is a global undertaking, this literature study shows that current biosimilar licensing pathways vary, especially among minor jurisdictions, leading to inefficiencies that might complicatethe global development of biosimilars. Optimizing and streamlining regulatory frameworks and data requirements, considering theextensive knowledge gained through advancements in analytical sciences and clinical experience with biosimilars, through dialogue and collaboration between regulators across jurisdictions, is crucial for reducing development costs and enhancing patient access to biologic and biosimilar medicines across the globe.

Evolving Global Regulatory Landscape for Approval of Biosimilars: Current Challenges and Future Considerations

DIA Europe 2024 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2024 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.

Join us in the vibrant city of Brussels for an unforgettable experience, where the power of collaboration will be on full display to inspire actionable outcomes and mobilise for solutions the life sciences’ community. Witness first-hand the profound impact of united efforts, gain valuable insights from across the drug development lifecycle, and play an active role in shaping the future of the pharmaceutical arena.

DIA Europe 2024

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.