Update Biosimilars 2026 - Regulatory Strategy in a Transforming Landscape

- EU Pharma Reform 2026: implications for biosimilar development and lifecycle planning - Revised exclusivity, Bolar exemption and patent-linkage - EMA expectations on (pre)clinical development and comparability - EU Biotech Act: incentives, manufacturing capacity and investment initiatives relevant for biosimilars - Global convergence: international streamlining of regulatory requirementsThis seminar covers the key regulatory shifts shaping the biosimilars landscape in 2026. Explore how the revised EU pharmaceutical legislation, the EU Biotech Act, and global regulatory convergence impact your biosimilar development and market entry strategy.LernzieleThis online training provides a compact, practice-oriented update on the regulatory and strategic developments that shape biosimilar projects in 2026. - Using the EU Pharma Reform and the EU Biotech Act as a guiding thread, you will explore what is already clear, where uncertainties remain, and how to translate the evolving framework into robust development and market-entry planning. - By the end of the seminar, you will be able to adapt your current regulatory strategy, identify the most relevant risk drivers for timelines and evidence generation, and derive concrete next steps for your biosimilar portfolio and global planning.ZielgruppenThis online seminar is designed for regulatory affairs professionals involved in biosimilar development, submission planning or lifecycle management. It is also suitable for colleagues from clinical development, CMC/biomanufacturing, patent/IP, market access and project management who contribute to strategic decisions and timelines.- Participants are expected to have a solid understanding of EU regulatory procedures.