Friday, June 20, 2025

Pharmaceutical Associations Sound the Alarm: Automatic Substitution of Biopharmaceuticals Threatens Supply Security and Germany’s Innovation Hub

The Federal Joint Committee (G-BA) has initiated the consultation process on automatic substitution of biopharmaceuticals – a step that has triggered serious concerns among leading pharmaceutical and biotech associations.

Allowing the exchange of off-patent biopharmaceuticals gives health insurance funds the option to negotiate exclusive rebate contracts with individual manufacturers. This creates intense price pressure and jeopardizes the secure supply of critical treatments for seriously ill patients.

BIO Deutschland, the German Pharmaceutical Industry Association (BPI), Pharma Deutschland, the Association of Research-Based Pharmaceutical Companies (vfa), and Pro Generika have long warned about the consequences: A short-term focus on the lowest price weakens Germany’s pharmaceutical sector, accelerates the relocation of production facilities abroad, and reduces technological sovereignty in the highly complex manufacturing of biopharmaceuticals.

The biosimilars market is already highly competitive. Established savings mechanisms such as open-house rebate contracts, mandatory manufacturer discounts, price referencing, and fixed reimbursement rates ensure substantial savings for health insurers without adding risks.

The associations emphasize that additional price pressure through exclusive contracts places manufacturers under significant economic strain and increases the risk of supply shortages – a reality already seen in the generics market. Furthermore, switching products at the pharmacy counter complicates traceability in the event of side effects and causes uncertainty among patients, especially when delivery devices or dosage forms change.

Despite repeated warnings, the G-BA is implementing a law passed in 2019 – a regulation that, according to the associations, is no longer appropriate given current geopolitical and supply chain realities. The COVID-19 pandemic exposed Europe’s dependence on generic medicines, highlighting the urgent need for a resilient supply and strong European production capabilities.

The pharmaceutical associations therefore call for a fundamental reassessment and urge policymakers to prioritize patient protection and the sustainability of Germany’s innovation landscape over short-term cost savings.