Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends

Best Practices, LLC conducted this timely benchmarking research that identifies key cost, quality and productivity metrics for the process of conducting bioequivalence studies required to bring a new generic drug to market. Specifically, this study looks at the growing trend in outsourcing for bioequivalence studies. In addition, the study also includes executive insights, lessons learned and best practices for productivity in the bioequivalence study process. Generic companies can use the comparative metrics in this study to evaluate their current bioequivalence testing programs.

Study Snapshot

Twenty executives at 18 leading generic pharmaceutical manufacturing companies participated in this benchmarking study. Most benchmark participants hold job titles at the director-level and above, and nearly half work in R&D organizations. The greatest number—42%—are located in the US, with another 37% in India. Qualitative and quantitative data for this study were collected through an online survey instrument.

Sample Key Findings

Use of Less Regulated Regions: A majority of participating companies (56%) outsource fewer than one-quarter of their bioequivalence studies to CROs in less-regulated regions, such as India, China, Russia and Eastern Europe.

• Current Outsourcing Locations: India gets the lion’s share of the Bioequivalence (BE) outsourcing that’s goes to less-regulated regions, with 78% of the Generic companies using CROs there.

• Future Outsourcing: Generic companies in the study expect to increase BE outsourcing levels to countries in less-regulated regions in the next 24 months, especially in India, where 65% expect increases.

• Volume of Outsourcing: Up to 80% of the benchmarked Generic companies routinely outsource key bioequivalence testing functions. All use outsourcing to some extent.

• Research Overview
• Benchmark Participants
• Key Findings & Observations
• Outsourcing & Geographic Trends
• Volume & Cost Metrics
• Bioequivalence Practices & Processes
• Clinical Quality Assurance Strategy, Structure & Performance
• Best Practices & Lessons Learned