Spain advances generic, hybrid and biosimilar drug adoption and pricing reforms

Spain's Ministry of Health released a detailed report on the adoption of generic, hybrid and biosimilar medicines in the National Health System for 2020‑2025. The study shows that biosimilars now account for 81.5% of packs in competitive markets, with hospital biosimilar varieties rising from 14 to 22 molecules and oncology biosimilars capturing over 90% of market share within three years. Pack volumes in hospitals increased from 19.8 million to 31.4 million, while pharmacy dispensing also grew significantly.

In parallel, the Council of Ministers approved the new Medicines and Medical Devices Law, replacing the 2015 framework. The legislation introduces a dynamic pricing model for off‑patent drugs, defines "strategic medicines" to prevent shortages, and creates mechanisms for early access to innovative treatments. It also strengthens reporting obligations for manufacturers and distributors and sets up an independent evaluation system to sustain the financial sustainability of the public health system.