2 min read
Operationalizing Adaptive Design for FDA's One-Trial Era
Operationalizing Adaptive Design for FDA's One-Trial Era
October 20, 2026 : 11:00 AM ET
On February 18, 2026, the FDA...
The development of biosimilar products in the U.S. has progressed since the regulatory pathway was established as part of the Affordable Care Act. Since then, the number of active biosimilar development programs has risen steadily. The market for these products is projected to exceed 100 billion dollars by 2028.
Listen to the full episode on Veristat’s Advancing Revolutionary Therapies Podcast to learn more about the analytical and clinical science of biosimilars and their regulatory pathway.
Learning Points
- Biosimilars vs. Generics
- Demonstrating biosimilarity to a reference product
- Evaluating comparative data between a biosimilar and reference product
- Differences between regular and interchangeable biosimilars
- Key regulatory considerations for development of biosimilars in the U.S.
- Financial considerations for biosimilar development
Meet Veristat. Learn More.
Get the Latest News
Categories
- Regulatory Consulting (141)
- Regulatory Submissions (135)
- Clinical Trial Regulations (123)
- COVID-19 (46)
- Strategic Consulting (39)
- Clinical Trials (35)
- Life At Veristat (20)
- Oncology (18)
- Events (16)
- Success Stories (13)
- Clinical Operations/Monitoring (12)
- Project Management (11)
- Decentralized Trials/Virtual Trials (9)
- Full-Service (9)
- Medical Writing (9)
- CMC (6)
- Data Management (5)
- Marketing Applications (5)
- Adaptive Design (4)
- Neurology/CNS (4)
- Statistics and Programming (4)
- Biologics (3)
- Cell Gene and RNA (3)
- Biometrics (2)
- Natural History (2)
- Psychedelics (2)
- Rare Diseases (2)
- AI (1)
- Global Markets (1)
- Hematology (1)
- InStat (1)
- Medical Affairs (1)
2 min read
Meet Veristat at the iC³ Life Science and Healthcare Innovation Summit
Aug 26, 2026 Veristat Events