EU and US Regulators Move to Streamline Biosimilar Approval Processes

Regulatory authorities on both sides of the Atlantic are moving to reduce requirements for biosimilar drug manufacturers. The FDA has reduced regulatory requirements for biosimilar drug manufacturers, a policy change aimed at streamlining the approval process for cheaper alternatives to costly biologic medications.

In Europe, the proposed EU Biotech Act includes measures that require the European Medicines Agency to develop and update guidance on a tailored regulatory approach for the development of biosimilars, in which the EMA shall consider a potential reduction of the clinical data required for the development and approval of biosimilars.

The EU Biotech Act was proposed by the European Commission on 16 December 2025 as part of a package of measures to improve resilience, competitiveness, and safety of the EU health sector. Despite the Union's strong scientific foundations, barriers like limited access to capital and regulatory complexity have left the EU lagging in biotech innovation, reflected in low venture capital investment, a decline in clinical trial activity, and a growing trend of start-ups relocating outside the EU.

The Act is designed in the legal form of an EU Regulation and will amend existing EU health, food, and biotech legislation, such as the Clinical Trials Regulation and the Food Safety Regulation. To enhance the EU's attractiveness for biotech investments and innovation, the proposal includes mechanisms to improve access to funding—particularly for Small- and Medium-sized Enterprises and start-ups—including an EU health biotechnology investment pilot in cooperation with the European Investment Bank Group, designed to support scale-up stages of biotech development.

The proposal also includes rewards for innovation, such as an additional 12-month extension to supplementary protection certificates for eligible biotech medicinal products developed and manufactured at least partially in the EU. Such additional SPC protection requires that innovation is taking place in Europe, as the pivotal clinical trials for an eligible product must be carried out in more than two EU Member States and at least one manufacturing step other than packaging, quality testing and certification must be performed in the Union.

One of the most important aims of the Act is to make Europe a faster and more attractive place to run clinical trials. The Act proposes to reduce the maximum authorization period for initial multinational clinical trial authorizations from 106 to 75 days. Timelines for the assessment of substantial modifications will be shortened as well. The current additional 50-day review period for clinical trials investigating ATMPs would be removed.

Assessment procedures would be harmonized and streamlined by a stronger role of the reporting Member States leading the scientific, ethical and regulatory assessment, with other Member States concerned being expected to generally rely on the RMS' assessment. Sponsors would be expected to use harmonized template documents to create the submission documents for Part II of the application dossier.

The Act introduces the concept of a single core dossier for an investigational medicinal product. This provides the opportunity for sponsors to create a single dossier which can be used as a basis for multiple clinical trials testing the same IMP. Subsequent applications for corresponding clinical trials can then refer to this core dossier, resulting in much simpler and more streamlined creation of submission documents for such subsequent applications.