Author: Florian Stieglitz, Consultant, Market Access

The German pharmaceutical policy landscape is currently changing in numerous ways. Developments originating from various initiatives are making the system increasingly data-driven, cost-focused, and demanding for manufacturers operating in the German market. The federal government’s renewed Pharma Dialogue, the establishment of the National Health Data Research Center (FDZ), and the ongoing debate about the role of biosimilars and their interchangeability as a mechanism to support the long-term financial stability for the statutory health insurance system are three recent developments that have an impact on how the system is evolving. The understanding of these three elements is essential, especially because of the structural reinforcement provided by each of them. 

Biosimilars – Cost Pressure 

The discussion of the interchangeability and automatic substitution of biopharmaceuticals with biosimilar products is an ongoing topic that most recently was discussed in an G-BA hearing, the SHI’s main regulatory institution, on 11 November. While biosimilar substitution can be an important source of efficiency gains, concerns have been raised within the industry by the political discussion. The BPI, a leading German association of the pharmaceutical industry, has expressed concerns about the implications of treating biopharmaceuticals like generics. These concerns include the risk of creating significant price pressure, the likelihood of production shifts abroad, and the potential for long-term supply vulnerabilities. Early signals of these risks have already emerged following substitution measures for parenteral preparations. It is emphasised by the association that substantial savings are already delivered by biosimilar competition without additional regulatory pressure; that freedom to guide patients through therapy changes is required by physicians; that traceability must remain intact to safeguard safety; and that stability in manufacturing and research would be undermined by exclusive discount contracts. The key message of the criticism is that patent-free biopharmaceuticals and generics are not equivalent, and maintaining supply security requires more than short-term cost-cutting logic. 

More data and dialogue 

The introduction of the Health Data Research Center (FDZ) at the Federal Institute for Drugs and Medical Devices has been a major step towards making health data accessible for research, regulatory processes and market access initiatives. The FDZ, while still in its early phase, is designed to provide prospective access to anonymised GKV data across sectors, with datasets extending back to 2009 and updated continuously from 2024 onwards. Access is limited to clearly defined “common good” purposes. Regulatory-defined purposes also enable data access for activities such as study planning, price negotiations, and the analysis of healthcare structures. However, there are essential procedural and strategic requirements, such as submitting applications in a timely manner and formulating precise research questions that will provide the required insightful data within the limited response received. The use of secure digital environments is also mandatory. As the FDZ matures, data accessibility may affect many elements of market access and the AMNOG assessment, making processes more empirical and systematic overall. For instance, companies might no longer have to rely on approximations for population size, treatment pathways or comparator costs. This is equally applicable to payers, who will have access to the same corpus of evidentiary data. 

The current Pharma Dialogue – Germany’s structured exchange between industry, payers, research institutions and government representatives – marks a notable shift in focus. While the previous administration emphasised scientific progress and the framework for clinical research, the renewed dialogue concentrates primarily on the economic conditions of Germany as a pharmaceutical hub. The process brings together multiple ministries (Health, Finance, Economic Affairs and Research) with key industry and payer associations, including VFA, Pharma Deutschland, BPI, Pro Generika, BVMed, Spectaris and the GKV-SV. Six working groups shape the agenda: overarching location policy (WG1); digitisation, research, AI and clinical studies (WG2); benefit assessment and EU HTA (WG3); pricing and reimbursement (WG4); biotechnology (WG5); and medical technology and devices (WG6). Recent publications on stakeholder positions point toward a more conditional understanding of innovation. Pharmaceutical progress is welcomed—but increasingly only when it strengthens system resilience, improves supply security or delivers measurable efficiency within publicly funded care. Although the coalition agreement calls for a new strategy to reinforce Germany’s pharmaceutical and medical technology sectors, the financial constraints highlighted by the GKV-SV implicitly tie industrial competitiveness to companies’ ability to operate within tighter budgetary boundaries. As a result, value arguments must demonstrate not only clinical benefit but also clear, quantifiable contributions to the broader healthcare system. While the Pharma Dialogue does not set formal policy, it signals a potential shift toward an HTA model that incorporates societal and system-level considerations alongside clinical evidence thus opening the door to more comprehensive value narratives in the future. 

The intensified biosimilar debate reflects growing pressure on Germany’s healthcare system, a theme that also recurs in the Pharma Dialogue, where the need for clearer evidence standards, stronger steering, and demonstrable system-level value is becoming increasingly pronounced. At the same time, the FDZ’s expanding real-world data infrastructure will open new opportunities for research and market access, while raising the evidentiary bar across AMNOG and related processes. 

In this environment, strategic planning cannot be reactive. Manufacturers must anticipate regulatory responses, understand how decision-makers interpret data, and prepare accordingly. Kintiga, a strategy consultancy specialising in market access, pricing, health economics, and cross-country HTA systems, supports this proactive approach. Its proprietary AMNOG database provides detailed insights into historical negotiation outcomes, comparator behaviours, and therapeutic-area pricing patterns – enabling forward-looking scenario modelling and structured preparation. To learn more about how Kintiga can support you, please get in touch. 

Sources

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