Looking ahead, the future growth of affordable medicine in Germany will be significantly fueled by the patent expirations of major biologic drugs and the subsequent introduction of biosimilars. Biologics, which are high-cost, high-value therapies, represent a massive cost-saving opportunity once they face generic-like competition.

Biosimilars—which are essentially the generic equivalent of complex biologics—are subject to similar price-constraining policies, although their regulatory path is more complex than small-molecule generics. Their successful uptake is viewed as the next critical step in achieving further cost savings for the SHI funds.

The regulatory environment is gradually adapting to streamline the introduction and prescription of these complex products, recognizing that they hold the key to long-term financial sustainability in high-cost therapeutic areas like oncology and immunology.

FAQ

Q: What is the main difference between a standard generic drug and a biosimilar? A: A generic drug is a chemical copy of a small-molecule drug, while a biosimilar is a close, but not identical, therapeutic copy of a complex, large-molecule biologic drug.

Q: Why are patent expirations of biologic drugs so important for German healthcare costs? A: Biologics are among the most expensive drugs, so the introduction of biosimilars after patent expirations offers the largest immediate potential for substantial SHI cost savings.