Regulator Spotlight
At the 2025 DIA Global Annual Meeting, held in Washington, DC in mid-June, USP International Government and Regulatory Engagement Director Chaitanya Koduri provided an update on USP’s efforts to address key challenges in global biosimilar development and regulation. After introducing USP and biosimilars, he discussed current challenges to their adoption and the role of advanced analytical tools in reducing the need for clinical data. Koduri then shared insights from a 2024 global regulatory consultation on biosimilar standards, the findings of which are helping shape USP’s strategy for supporting biosimilar development, standardization and harmonization.
CLICK HERE to view the issue.
ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion in which regulatory agency and pharmacopeia leaders address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.