Declaration of the objectives and scope of the European Biotech Act 

• The European Commission has unveiled the European Biotech Act, signalling a major shift in EU biotech policy. The initiative aims to strengthen Europe’s competitiveness in health biotechnology and biologics development.
• Health biotechnology already represents more than 80% of the value of the EU biotech sector, employs over 900,000 people, and contributes close to €40 billion annually to the European economy.

European Biotech Act Objectives

A central pillar of the Biotech Act is regulatory simplification, particularly in clinical development. The Commission proposes significant changes to shorten and harmonise multinational clinical trial authorisations across Member States. End-to-end approval timelines for multinational trials are expected to decrease from up to 75 days to as few as 47 days in straightforward cases, with further reductions for trial modifications. From 2026, a new FAST-EU initiative involving 23 Member States will pilot faster and more coordinated authorisation procedures.

Financing and industrial scale-up form the second major focus of the European Biotech Act. In cooperation with the European Investment Bank, the Commission plans to launch a dedicated health biotech investment pilot intended to mobilise up to €10 billion in public and private funding. The initiative targets the full lifecycle of biotech development, from early research to large-scale manufacturing, addressing long-standing gaps in risk financing.

Scope of the European Biotech Act

Biotechnology has been included in the EC’s political program for 2024-2029 as one of the key technologies for the EU’s economy and security. The European Biotech Act is designed to address these challenges by reducing regulatory complexity, accelerating development timelines, and improving access to investment capital for biotech companies operating in Europe.

This policy shift creates new opportunities for companies developing biologics such as monoclonal antibodies, biosimilars, antibody-based therapeutics, recombinant proteins and vaccine antigens. Faster approvals, clearer regulatory pathways and improved access to capital reduce uncertainty across the development lifecycle. The focus on harmonisation and single regulatory pathways is particularly relevant for complex biologics, where fragmented national processes have historically increased cost and delayed patient access. By strengthening Europe’s manufacturing base and supporting high-impact strategic projects, the Biotech Act also reinforces supply chain resilience and long-term competitiveness.

Prepared by:

Jakub Knurek

Marketing Specialist

j.knurek@mabion.eu

Jakub Knurek

Marketing Specialist

Jakub Knurek is a marketing and business development expert specializing in CDMO operations with scientific and biopharmaceutical background. During the COVID-19 pandemic, he contributed to the development of the Novavax protein vaccine. As a side project, he runs his own pharma company.

As the author of numerous articles, he is recognized as an important voice of the younger generation of scientists. He is a member of Mabion’s representation at industry trade shows, including BIO International Convention 2025 in Boston, 2nd Global Biologics India 2025 in Hydrabad, CPHI 2024 in Milan, CPHI 2023 in Barcelona, Life Sciences Baltics 2023 in Vilnius. He actively participates in academic, business and industry discussions, such as the “Building the Future Pharma Workforce” panel at CPHI Milan 2024.

Sources and further reading

1. European Comission, New measures to make EU health sector more innovative, competitive and resilient. 2025.
2. EU Biotech Act website