Biosimilar substitution: Health insurance funds welcome G-BA plans, industry sounds the alarm

Since 15 March 2024 Pharmacies are obliged to exchange certain biotechnologically produced medicines for cheaper Biosimilars . The basis for this is a substitution list of the The Federal Joint Committee (G-BA) currently includes six active substances. The G-BA plans to expand this exchange list: A commentary procedure on the first preliminary draft resolution is expected in the foreseeable future.

This is causing unrest in the industry. The Pro Biosimilars working group, the German Pharmaceutical Industry Association (BPI), Pharma Deutschland, the Association of Research-Based Pharmaceutical Manufacturers (vfa) and the research-based pharmaceutical companies (vfa) are warning against the expansion of the substitution list. "The possibility of exchanging patent-free biopharmaceuticals like generics gives statutory health insurance funds the option of exclusive "To conclude discount agreements with individual manufacturers," a joint press release states. This leads to extreme price pressure on the affected companies.

Pharmaceutical and biotech associations have been warning of these consequences for years. "A short-term focus on the lowest price jeopardizes the care of seriously ill patients and simultaneously weakens Germany as a pharmaceutical and biotech location," they continued. Cost pressure is increasing the relocation of production facilities to non-European countries, which is accompanied by a loss of technological sovereignty in the highly complex manufacturing processes of biopharmaceuticals.

"The desire for further savings ignores the existing reality: The biosimilar market is already highly competitive, and most preparations achieve high prescription rates. In addition, proven cost-saving instruments—such as open-house discount agreements, mandatory manufacturer rebates, the auxiliary tax, and fixed amounts—are already generating substantial savings for health insurance funds," the associations explained.

Additional price pressure from exclusive contracts puts manufacturers under considerable economic pressure and increases the risk of supply shortages – which is "already a reality" in the generics market. Furthermore, exchanges in pharmacies complicate traceability in the event of side effects and lead to uncertainty among patients, especially when application devices or dosage forms change.