Navigating Germany’s Biosimilar Policies: A road to healthcare accessibility

Abstract

Biosimilars, medicines highly similar to another already approved biological medicine, are cost-effective alternatives to biologicals and are crucial for healthcare accessibility. While similar to reference medicines, they are not identical but undergo rigorous approval processes ensuring safety and efficacy. Germany has a high uptake of biosimilars and appears as a leader in biosimilar adoption on a global scale, thus understanding Germany's approach can exemplify effective policy integration. This analysis aims to evaluate Germany's biosimilar policies, its effects on uptake and pricing, and stakeholder perceptions.

EMA established guidelines for biosimilars in 2004, outlining biosimilar assessment criteria used for market authorization. Germany adopted biosimilar use recommendations in 2008, which were further refined in 2017 and 2021. In 2019, the GSAV law enabled the Federal Joint Committee (G-BA) to regulate biosimilar interchangeability. Subsequently, the G-BA adopted guidelines for automatic substitution of biosimilars in pharmacies in 2023 (§40B to Medicinal Products Directive), which have become effective from March 15 2024. Germany's biosimilar policies have led to significant cost reductions and increased biosimilar uptake over the years, particularly in anti-TNF biologicals, though adoption rates vary regionally, with lower rates in economically disadvantaged areas.

The GSAV and subsequently automatic substitution were met with a lot of critique from pharmaceutical associations, physician and hospital associations, and patient organizations. Payers, the sick funds, did respond positively to the law. When looking at policies from other European countries, positive policy elements can be identified that could be adopted to further strengthen Germany’s policies, such as physician incentives, hospital financing mechanisms, public procurement policies, education for healthcare professionals and inclusion of biosimilars in reference price systems. However, effective policy elements are often hard to translate to other countries due to differences in healthcare systems.

Debates around Germany’s biosimilar substitution persist, especially regarding the recently implemented automatic substitution due to concerns about interchangeability. Interchangeability is crucial for biosimilar uptake, but doubts among physicians remain. Scientific evidence supports interchangeability, but practical challenges exist, including the need for a robust pharmacovigilance system. Germany's strengths include high national uptake, integration into medical practice, and proactive measures for fast adoption of new biosimilars. However, regional variations and criticisms on the mandatory substitution, indicate areas for improvement. Future perspectives emphasize the need for continued education, stakeholder engagement, and evidence-based policymaking. Collaboration with the EMA to clarify interchangeability and harmonize policies could provide beneficial to increase biosimilar uptake on a continental level. Overall, while Germany's biosimilar policies set a global example, further improvements are necessary for to integrate biosimilars better into the future healthcare system.