Inotiv and Xentria partner together achieveing an FDA Regulatory Submission one year ahead of schedule
Inotiv partnered with Xentria to accelerate biosimilar insulin aspart development through advanced bioanalytical and clinical expertise. By deploying GLP/GCLP-compliant PK/PD assays and innovative LC-MS/MS methodologies, Inotiv helped facilitate FDA regulatory submission one year ahead of schedule. This case study highlights how integrated bioanalysis, statistical rigor, and operational agility can de-risk biosimilar development, shorten timelines, and support faster market access—helping drug developers meet rising global demand for affordable biologics.
Explore this case study to learn about:
- Understand how LC-MS/MS improves biosimilar PK specificity and regulatory confidence
- Learn strategies to accelerate FDA biosimilar submissions
- See how integrated clinical and bioanalytical workflows reduce development timelines
Click here to download this case study!
