FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway - 09/23/2026

Date:

September 23 - 24, 2026

Day1:

Wed, Sep 23 8:00 a.m. - 04:30 p.m. ET

Day2:

Thu, Sep 24 8:00 a.m. - 04:30 p.m. ET

Location:

Event Location

Attend In Person or Virtually

In Person: The Universities at Shady Grove

Building II

9630 Gudelsky Drive Rockville, MD 20850 United States

This workshop is free to attend virtually

Register Here

Event Details

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 productsImpurities and immunogenicityGLP-1 characterization and sameness assessmentOrally 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

These topics reflect some of the current challenges facing GLP-1 generic drug development today and the scientific innovations being deployed to overcome them.

For more information, please visit the Center for Research on Complex Generics website for this Workshop.

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