On 16 December 2025, the European Commission published a proposal for the European Biotech Act (“Biotech Act”). The aim of the proposal is to strengthen the EU’s competitiveness in the field of biotechnology and position Europe as a globally competitive biotech hub. The Biotech Act is designed as a legislative package that amends relevant EU legislation and adds new instruments to promote biotechnological innovation. It is primarily addressed to all companies with biological products, regardless of their size, but places particular emphasis on biosimilars and ATMPs. Especially for specialized biopharma companies, this gives rise to the following far-reaching regulatory and structural changes:

1. Accelerated procedure for clinical trials

A key element of the Biotech Act is the acceleration of clinical trials through the amendment of the Clinical Trials Regulation (Regulation (EU) No. 536/2014). In particular, studies that are considered “strategic health biotechnology projects” will be subject to an accelerated approval procedure with shorter approval periods. EU-wide central coordination is also intended to prevent national inconsistencies in multinational clinical trials.

2. Promoting the production of biosimilars

Another core aspect of the Biotech Act is to promote the EU-wide production of biosimilars by utilizing unused capacity and improving financing options. Regulatory simplifications are intended to make investments more attractive, supplemented by data-based approaches to evaluation.

3. IP incentives and anchoring in the EU

Through the creation of IP incentives, the Biotech Act aims to anchor the value creation from clinical trials within the EU. The Biotech Act provides for an extension of the supplementary protection certificate (SPC) by up to twelve months for biological medicinal products, including ATMPs, provided that they are developed and produced in the EU.

4. Financial support

The planned funding and investment measures of the Biotech Act are also of relevant importance for biopharma companies. For example, a European investment facility for health biotechnology (“EU Health Biotechnology Investment Pilot”) is intended to close financing gaps.

5. Digitalization and regulatory efficiency

The Biotech Act emphasizes the central role of digitalization in biotechnology research and development. Based on the principle of „digital by default,“ connected data and AI-driven analyses are expected to increase the efficiency of the development and manufacturing processes of biopharmaceuticals. For manufacturers of biological medicinal products, it is also relevant that validated AI models and simulation data can, in the future, complement clinical data. Furthermore, the use of AI in clinical trials is to be facilitated to promote personalized therapies, such as ATMPs.

6. Outlook for the future

The Biotech Act offers significant advantages to biopharma companies that consolidate clinical trials and production capacities in the EU, including accelerated approval procedures, extended protection periods, and improved financial conditions for market launch. The adoption of the Biotech Act is expected to be adopted in the second half of 2026. Companies with a focus on biotechnology should therefore identify suitable projects at an early stage that can be designated as “strategic health biotechnology projects” once the Biotech Act comes into force.