13 Tips to Overcome Design & Operational Challenges in Biosimilar Clinical Development
The explosion of interest in biologic therapeutics, both in its potential cost benefits for patients and large growth potential, has created a significant buzz in the drug development industry. Since biosimilar development is still relatively new, there are still questions about how to properly run an effective and efficient clinical trial. The approval of the first Biosimilar in the United States created a blueprint for future submissions, but the evolving competitive and regulatory landscape makes it difficult to stay on top of development updates.
Based on the experience of our internal team, we have created a series of 13 study design and operational tips for your use and reference in the development of Biosimilar programs. Click through each of the tips below: