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The EU Biotech Act: Unlocking Europe's Potential

In an era defined by scientific innovation, biotechnology stands at the forefront of medical advancement, offering transformative treatments for a wide range of diseases including cancer, cardiovascular conditions, inflammatory diseases, and rare genetic disorders. To ensure Europe remains a leader in this critical field, Amgen welcomes the European Commission’s ambitions to promote biotech R&D through the upcoming proposal for a Biotech Act. Moreover, Amgen has developed a series of recommendations to complement the existing and updated regulatory frameworks by reducing unnecessary bureaucratic processes and supporting faster access to innovative biotechnology medicines across the EU.

A more detailed fact sheet of Amgen’s recommendations for the Biotech Act can be accessed here.

1. Establishing a centralised and efficient clinical trials framework

Despite progress through the Clinical Trial Regulation, inconsistencies at the national level continue to create challenges for biotech research. Amgen proposes:

  • A centralised, coordinated assessment process for biotech clinical trials, managed under the European Medicines Agency (EMA). This would bridge gaps, reduce duplication, and ensure continuity from clinical trials through marketing authorisations and post-marketing monitoring.
  • A unified framework for combination products, which involves both medicinal products and medical devices or diagnostics.
  • A standardized ethics review process across member states, which will help accelerate multi-country trials and deliver innovative therapies to patients faster.

2. Accelerating Approval Pathways

Speed is paramount when it comes to life-saving biotechnology treatments. Current regulatory timelines can delay patient access, including for therapies targeting orphan diseases. Amgen recommends an expedited (e.g. 120-day) review pathway for biologics with strong preclinical and early clinical evidence addressing high unmet medical needs, complementing the EU’s Pharmaceutical Package proposals.

3. Building Regulatory Expertise and Capacity

The complexity of biotech products demands regulatory systems staffed by experts with deep scientific understanding. To future-proof the European regulatory framework, Amgen suggests:

  • Specialising EMA regulators in biotech science through a centrally managed talent pool accessible across member states.
  • Expanding training programmes like the Regulatory Training Academy to include biotech-specific modules.
  • Establishing a biotech scientific advisory panel within EMA to provide guidance on cutting-edge biotechnologies.
  • Creating a Regulatory Innovation Fund to finance projects aimed at regulatory modernization, such as regulatory sandboxes and digital tool enhancements.

4. Modernising Supply Chain and Manufacturing Rules

Current EU import testing rules—rooted in 1970s practices—impose unnecessary burdens that delay patient access and impact environmental sustainability. Amgen calls for a modern approach, including:

  • Mutual recognition of quality testing from trusted third countries with mature regulatory systems, eliminating redundant import testing for products like biologics.
  • Updating manufacturing data requirements to reflect the unique characteristics of biotech products.
  • Encouraging regular updates to EMA manufacturing guidance, ensuring it keeps pace with scientific advancements.

5. Supporting Small and Medium-sized Enterprises and Protecting Intellectual Property

Small and medium-sized enterprises (SMEs) and start-ups are vital engines of biotech innovation but often lack the resources and expertise to protect their intellectual property (IP) effectively. To strengthen the biotech ecosystem, Amgen proposes:

  • Specialised IP support services for SMEs to help them strengthen and leverage their IP.
  • Enhanced cooperation between the European Patent Office and national IP offices, streamlining cross-border biotech patent enforcement.

Conclusion: A Defining Moment for European Biotechnology

Europe stands at a pivotal moment. To retain a competitive health care sector, the EU must take action to promote innovation, strengthen its startup ecosystem, and attract global investment in R&D for strategic autonomy. As one of the world’s leading biotechnology companies operating in more than 100 countries with a team of over 28,000 employees, Amgen is committed to partnering with European institutions, industry peers, and stakeholders to deliver on this shared vision.

Download a detailed fact sheet of Amgen’s recommendations for the Biotech Act here.