Navigating the GLP-1 Generic Drug Pathway

This two-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 peptide products, address manufacturing quality considerations, and tackle the unique challenges associated with drug-device combination products, where applicable.

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 analysis (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

Join us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies, pharmaceutical industry, and academia. All attendees will benefit from insights shared by a diverse group of speakers, including FDA officials, industry leaders, and renowned academics. This workshop offers a unique opportunity to:

• Understand the latest regulatory thinking on generic GLP-1 product development
• Learn about cutting-edge analytical and formulation approaches for peptide products
• Gain insights into device design, human factors, and combination product development
• Network with peers and experts in the field
• Explore real-world case examples and best practices
• Participate in collaborative discussions on emerging challenges

Join us to be part of the conversation shaping the future of generic GLP-1 product development.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussion (not including the small group working sessions)

In-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring:

• Small group working sessions at the end of each day will facilitate collaborative problem-solving and discussion of complex technical and regulatory issues impacting GLP-1 generics. During these working sessions, attendees will help identify actionable next steps to address challenges with generic product development and regulatory assessment.
• Collaborative interactions with experts from industry, consulting groups, academia and FDA for clarifying regulatory expectations and exploring insights into regulatory standards
• Networking opportunities designed to foster collaboration and contribute to moving the field forward.

Workshop Topics

• Regulatory Pathways and Clinical Context
• API Characterization and Peptide Manufacturing
• Oral Formulation Development and Bioequivalence
• Device Design and Human Factors
• Drug-Device Integration and Quality

Audience

This workshop is designed for professionals involved in the development, manufacturing, and regulation of generic products. The target audience includes pharmaceutical scientists (formulation and product development scientists, analytical chemists, quality assurance and control experts), regulatory affairs professionals, device engineers, human factors specialists, clinical development professionals, and manufacturing experts. Additionally, the workshop will be valuable for academic researchers in pharmaceutical sciences, representatives from contract research organizations (CROs) and contract manufacturing organizations (CMOs), regulatory agency staff, and healthcare professionals interested in generic complex drug products. The content is tailored to accommodate participants with varying levels of expertise in peptide products and drug-device combination products, from those seeking to understand the fundamentals to advanced practitioners looking to stay abreast of the latest regulatory considerations and development strategies.

• Virtual Attendance is optimal for an audience who would like to have access to workshop content from anywhere, eliminate travel time and expenses, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.
• In-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement, immersive learning, interactive sessions and group activities.

Registration Fees:

• This workshop is FREE for virtual attendees.

• The combined cost for both days of in-person attendance and activities is:
  • $350, in-person attendees – general
  • $150, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)

For faculty and students from the University of Maryland, Baltimore, The Universities at Shady Grove, and University of Michigan, please contact CRCG (info@complexgenerics.org) regarding registration.

Continuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person, when requested.

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.

DAY 1

Session 1: Opening Remarks and Regulatory Foundations

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.

Session 2: API Characterization and Sameness Demonstration

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.

Session 3: Recombinant Peptide Production and Host Cell Impurities

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.

Session 4: Small Group Working Sessions

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.

DAY 2

Session 5: Device Design, User Interface, Human Factors, and Quality

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, bioequivalence, and FDA expectations for studies, and addresses device engineering and drug-device compatibility considerations that impact performance, bioequivalence, and ANDA review for GLP-1 generic combination products. Topics include the landscape of GLP-1 drug-device combination products in the US market, regulatory framing of “acceptable” UI differences, current CUHF study guidance and design fundamentals, case examples for pen injectors and autoinjectors, alternative CUHF approaches, device platform-based approaches for CA and HF data sharing, engineering considerations for generic GLP-1 injectors and drug-device interfaces, and CMC considerations for device evaluation. The session provides practical insights into study design, recruitment challenges, and regulatory expectations for developing robust GLP-1 generic combination products.

Session 6: Oral Semaglutide: Bioequivalence, Regulatory Considerations, and Oral Peptide Delivery

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.

Session 7: Small Group Working Sessions – Day 2

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.