Biosimilar Experts: No Scientific Rationale For Requiring Bridging Studies

In a newly published paper, two biosimilar experts make a scientific case for abandoning requirements that biosimilar sponsors conduct bridging studies between foreign biologics and U.S. licensed reference products before using non-U.S. samples for the testing required for approval. The experts contend that bridging studies have been required solely out of precaution and cost developers at least several hundred thousand dollars. They add that subjecting human subjects to those trials could potentially be unethical. The push for FDA to revisit...