Current Challenges in Developing Biosimilars
The development of biologics calls for overcoming lot many challenges. As comparisons are being drawn from the initial stages, it is very important to have proper scientific as well as strategic approached taken for the successful development of these Biosimilars. The need for overcoming the challenges continues till the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to quality by design (QbD).
- Approval Process for Biosimilar Products
- Clinical Trial Design
- New Trends in Delivery Systems
- Improving the Drug Performance