Using a reduced form binary econometric model, we analyze the determinants of pharmaceutical companies entry decisions into new submarkets. Our sample includes data for pharmaceutical companies over the period 1987-1998 for seven countries. Estimation is done both at the aggregate level and at a...

Biosimilars are close copies of biologic drugs, a group of complex pharmaceutical products that cannot be exactly replicated. The United States Congress passed regulation promoting biosimilar entry in 2010. Since then, the FDA has approved more than 30 biosimilars. We study how the entry of...

The paper uses a real option approach to investigate the impact of performance-based risk-sharing agreements for the reimbursement of new drugs in comparison with standard cost-effectiveness thresholds. The results show that the exact definition of the risk-sharing agreement is key in...