By Anna Rose Welch, Editor, Biosimilar Development
Developing a biosimilar is a highly scientific process. To ensure the biosimilar demonstrates the same efficacy and safety profile as the reference product, the science and clinical data have to match up. However, as Ruediger Jankowsky, managing director of Cinfa Biotech, says, a company should approach biosimilars from the “pharmacist’s perspective,” which extends far beyond the science of a biosimilar.
By Zhihong Lai, GSK, and Anna La Noce, Worldwide Clinical Trials
The global development of a biosimilar product is a complex affair, lined with potential design pitfalls and operational missteps to be avoided. Owing to the focus on demonstrating biosimilarity and not safety and efficacy de novo, designing an adequate Phase 3 efficacy study of a biosimilar may present some unique challenges.
Read this week’s blog posts on:
• Presidential Budget Pushes For Lower U.S. Biologics Exclusivity Period
• FDA Committee Gives Nod To Celltrion For Full Remicade Label
• Biocon To Seek FDA Approval For Biosimilars