Market access for biopharmaceuticals: new challenges.

Biotechnology firms face new challenges as biologics account for an increasing share of product approvals and pipelines and their high costs are under scrutiny by regulators, employers, and consumers. Although the first generation of biologics often targeted niche markets with little impact on payers' total costs, the current product wave addresses larger populations. To meet the needs of all stakeholders, manufacturers must adopt an evidence-based approach including three principles: demonstration of clinical and economic value, price evolution according to market conditions (from orphan diseases to large areas such as diabetes), and an early timetable integrating clinical and economic endpoints.