Regulatory, commercial considerations are the primary drivers for biosimilar development
Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from Quintiles, titled An Integrated Approach to Biosimilar Development & Commercialization.
Multiple EU policies hinder the importation and use of biotech crops from the United States, including delays in approvals of new biotech traits; commercially infeasible requirements on biotech content in food products under EU Traceability and Labeling Regulations; and state-by-state restrictions on biotech imports.