FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway

FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway is organized by U.S. Food and Drug Administration (FDA) and will be held from Sep 23 - 24, 2026 at The Universities at Shady Grove, Rockville, Maryland, United States of America.

Description:
This 2-day workshop will address some of the key product development and regulatory assessment considerations for generic glucagon-like peptide-1 (GLP-1) agonist products. The goal of this workshop is to provide clarity and foster discussions on evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic generic peptide products, address manufacturing quality considerations, and tackle the unique challenges associated with drug-device combination products, where applicable.

Virtual Attendance:
All attendees will enjoy a series of expert-led presentations and panel discussions that provide valuable insights into the intricacies of developing generic GLP-1 products across diverse topic areas, including synthetic and recombinant manufacturing, analytical characterizations, oral peptide formulation development, device user interface and human factors, and device quality and integration.

In-Person Attendance:
In-person attendees will enjoy all the benefits of virtual attendance and, additionally, interact directly with experts from FDA, academia, industry, consulting groups, and others to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. These high-engagement scientific interactions will be facilitated through two in-person-only sessions:

• A session dedicated to informal networking and candid dialogue with FDA, Industry, Academic, and other subject matter experts about scientific and regulatory challenges for GLP-1 generic products, including sections focused on:
  • Device constituents of drug-device combination products
  • Impurities and immunogenicity
  • GLP-1 characterization and sameness assessment
  • Orally administered peptides
• A guided session for small groups of in-person attendees to elucidate and work through specific challenging issues for GLP-1 generic product development and assessment.

The 2-day workshop will cover critical areas such as:

• Regulatory pathways and clinical contexts for GLP-1 products
• Comprehensive approaches to demonstrating GLP-1 active ingredient sameness, analytical characterization strategies, and impurity profiling
• Best practices for characterizing and controlling recombinant peptide production impurities
• Formulation and delivery innovations, bioequivalence study design for oral peptide formulations, and absorption enhancement technologies
• Comparative analyses of device user interfaces and considerations for other design differences
• Quality considerations for generic injectors, drug-device interface and compatibility, and submission coordination strategies

Key areas of focus include:

• Regulatory and Scientific Foundations: Current FDA scientific thinking on generic GLP-1 product development, Product-Specific Guidance (PSG) development, and in vivo BE studies for GLP-1 oral products
• Active Pharmaceutical Ingredient (API) Characterization and Manufacturing: Comprehensive approaches to demonstrating API sameness, analytical characterization strategies, impurity profiling, and sameness assessment for peptide products
• Recombinant Peptide Production: Best practices for controlling host cell impurities, regulatory expectations, and risk assessment strategies
• Oral GLP-1 Formulation Development: Formulation and delivery innovations, bioequivalence study design for highly variable products, absorption enhancement technologies, and drug product quality expectations
• Device User Interface and Human Factors: Comparative analyses (CA) of device user interfaces, Comparative Use Human Factors (CUHF) study design and case examples, alternative approaches, and device platform strategies
• Device Quality and Integration: Quality considerations for generic injectors, drug-device interface and compatibility, manufacturing quality control, and submission coordination strategies

Introduction to the Workshop:
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.