Case Study: Sameness Evaluation of Liraglutide Generic project submission to USFDA

Case Study: Sameness Evaluation of Liraglutide Generic Project Submission to USFDA How do pharmaceutical companies prove that a generic peptide drug is truly “the same” as the reference product? In this video, we break down the complete case study of a Liraglutide Sameness Evaluation conducted for ANDA submission to the U.S. FDA. Liraglutide, a complex GLP-1 peptide analog used in products like Victoza® and Saxenda®, requires advanced analytical characterization beyond standard generic drug testing. This video explains how peptide mapping, LC-HRMS, LC-MS/MS, impurity profiling, and forced degradation studies are used to demonstrate molecular sameness and regulatory compliance. In this video, you’ll learn: • FDA expectations under the 505(j) ANDA pathway • Why liraglutide sameness testing is technically challenging • How LC-MS/MS confirms peptide sequence identity • Importance of lipid conjugation verification at Lys26 • Role of impurity profiling and degradation studies • How regulatory-ready analytical documentation is prepared This case study is valuable for: ✔ Generic pharmaceutical companies ✔ Regulatory affairs professionals ✔ Peptide scientists and analysts ✔ Pharmaceutical R&D teams ✔ ANDA submission consultants Read the full technical case study here: https://resolvemass.ca/liraglutide-sa... Subscribe for more insights on: • Peptide characterization • Mass spectrometry applications • Generic drug development • FDA regulatory science • ANDA analytical strategies #Liraglutide #USFDA #ANDA #GenericDrugs #PeptideCharacterization #MassSpectrometry #LCMSMS #GLP1 #PharmaceuticalAnalysis #RegulatoryAffairs #PeptideMapping #PharmaRND #DrugDevelopment #AnalyticalChemistry #FDAApproval #Bioanalysis #ResolveMass #PeptideTesting #PharmaceuticalIndustry #HRMS