Navigating the GLP-1 Generic Drug Pathway

This two-day hybrid (virtual and in-person) workshop focuses on exploring the scientific, regulatory, and technical considerations for developing generic GLP-1 products throughout development. The workshop will include comprehensive sessions examining regulatory pathways and clinical context, API characterization and manufacturing, oral formulation development, device design and human factors, and drug-device integration strategies. The program features expert presentations from regulatory scientists across multiple FDA offices, industry leaders from both innovator and generic companies, device manufacturers, and academic researchers, complemented by interactive Q&A panels and small working group discussions for in-person attendees at the end of each day. This collaborative forum aims to advance understanding of the unique challenges in generic GLP-1 development and foster dialogue on best practices, emerging approaches, and regulatory expectations for these complex products.

Info: Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) This opening session establishes the regulatory and clinical framework for generic GLP-1 product development. The session provides an overview of the currently available GLP-1 products for generic products to reference. It will also explore the economics and patent landscape of GLP-1 products, providing essential background for understanding the market dynamics and development considerations.

Info: Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
This session establishes regulatory expectations and scientific approaches for demonstrating API sameness in generic GLP-1 peptide products. Topics include structural and functional equivalence demonstration, comprehensive analytical characterization strategies (including higher-order structure analysis and mass spectrometry), peptide-specific stability challenges and shelf-life determinations, impurity profiling and characterization, and an update on peptide impurity qualification. The session will address common deficiencies and provide practical guidance on analytical methods and data requirements.

Info: Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
This session examines best practices for controlling host cell impurities in recombinant peptide production, drawing on regulatory expectations and experience from 505(b)(2) applications and biologics (including insulins). Attendees will learn about manufacturing considerations for recombinant peptides, analytical approaches for host cell protein detection and quantification and regulatory expectations for impurity control and cleanup processes.

Info: Format: Interactive Working Sessions Around a Roundtable (In-Person Only)
In this interactive and collaborative session, in-person attendees will participate in focused discussions on key topics from Day 1, including API characterization challenges, analytical method development, stability strategies, and manufacturing considerations. Guided by experienced moderators, participants will engage in immersive round-table deliberations on selected high-impact topics, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include API characterization and demonstrations of sameness, as well as recombinant peptide production and host cell impurities.

Info: Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
This session examines how device user interface differences in GLP-1 products affect substitutability, BE, and FDA expectations for Comparative analysis (CA) and CUHF studies, and addresses device engineering and drug-device compatibility considerations that impact performance, bioequivalence, & ANDA review for GLP-1 generic combination products. Topics include landscape of GLP-1 drug-device combination products in the US market, regulatory framing of "acceptable" UI differences, current CUHF study guidance & design fundamentals, case examples for pen injectors & autoinjectors, alternative CUHF approaches, device platform-based approaches for CA & HF data sharing, engineering considerations for generic GLP-1 injectors and drug-device interfaces, and CMC considerations for device evaluation. Session provides practical insights into study design, recruitment challenges, and regulatory expectations.

Info: Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
This session addresses the regulatory and scientific challenges of developing generic oral semaglutide tablets, drawing on FDA's experience with PSG development and generic application review. Topics include PSG development and bioequivalence study design, strategies for managing high intrasubject pharmacokinetic variability, FDA perspectives on drug product specifications and quality expectations, clinical considerations for oral peptide formulation approaches, and permeation enhancer selection for oral peptide delivery. Together, these presentations provide practical insights into the unique challenges of developing generic oral semaglutide products and the evolving landscape of oral peptide delivery technologies.

Info: Format: Interactive Working Sessions Around a Roundtable (In-Person Only)
In this interactive and collaborative session, in-person attendees will participate in focused discussions on key topics from Day 2, including oral formulation challenges, device design considerations, human factors study approaches, and combination product development strategies. Guided by experienced moderators, participants will engage in immersive round-table deliberations on selected high-impact topics, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include CUHF study challenges, subgroup analysis and extrapolation, device platform approaches, and submission coordination strategies.
The workshop will conclude with a summary of key takeaways and future directions for generic GLP-1 product development.

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Host or Publisher Center for Research on Complex Generics