
What you will learn?
- Introduction to Biosimilars
- What are Biosimilars?
- Biosimilars vs. Generic Medicines
- Biological Medicines and Their Sources
- Importance of Biologics
- Evolution of Biosimilars
- Biosimilar Approval Pathways
- Pharmacokinetics & Pharmacodynamics - Small Molecules
- Pharmacokinetics & Pharmacodynamics – Biologics
- Role of Biologics and Biosimilars in Cancer Treatment
- Manufacturing and Marketing Challenges
- Regulatory & Patent Challenges
- Interchangeability of Biosimilars
- Biologics License Application (BLA)
- CGMP Compliance
- EU Biologics & Biosimilars Regulations