German pharma associations oppose automatic substitution of biosimilars
Industry groups warn that the G-BA's plan to allow automatic substitution of biosimilars could threaten supply security and undermine domestic pharmaceutical production.
The German Federal Joint Committee (G-BA) has initiated a process to introduce the automatic substitution of off-patent biological medicines. Five major pharmaceutical and biotech associations, including Pharma Deutschland and vfa, have issued a joint statement criticizing the move, warning that it will force manufacturers into exclusive discount contracts, significantly increasing economic pressure.
Industry representatives argue that the biosimilar market is already highly competitive and that existing cost-control measures are sufficient. They warn that further price-driven mandates threaten to push manufacturing facilities out of Europe, thereby undermining the continent's technological sovereignty in complex pharmaceutical production.
Concerns were also raised regarding patient safety. The associations pointed out that automatic substitution at the pharmacy level complicates the traceability of adverse events and creates uncertainty for patients if delivery devices or administration methods differ.
Critics label the policy as outdated, noting that it implements a 2019 law that fails to account for current geopolitical realities. Following the supply chain vulnerabilities exposed during the COVID-19 pandemic, the industry groups argue that the focus should be on building a resilient manufacturing base rather than aggressive cost-cutting measures.