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Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International

Elif Car1, Liese Barbier1, Ingrid Schwarzenberger2

  • 1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|October 21, 2025
PubMed
Summary

Stakeholders identified key recommendations to streamline biosimilar development and achieve global regulatory convergence. These include enhancing education, promoting reliance, and aligning requirements for faster drug approval.

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