open access publication

Article, 2024

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

Frontiers in Medicine, ISSN 2296-858X, Volume 11, Page 1335928, 10.3389/fmed.2024.1335928

Contributors

Klein, Kevin (Corresponding author) [1] Heisterberg, Jens [2] Stolk, Pieter [1]

Affiliations

  1. [1] Exon Consultancy, Amsterdam, Netherlands
  2. [NORA names: Netherlands; Europe, EU; OECD];
  3. [2] Novo Nordisk (Denmark)
  4. [NORA names: Novo Nordisk; Private Research; Denmark; Europe, EU; Nordic; OECD]

Abstract

Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine. Whereas biosimilars are subject to a dedicated regulatory framework in the EU, synthetically produced follow-on products are not eligible for assessment through this pathway, requiring approval via the traditional generic pathway under Article 10 (1), or via the hybrid pathway under Article 10 (3). This review presents an overview of recent developments in the field of synthetic peptides referencing biological originators in the EU. The use of different regulatory procedures can have potential implications for regulatory assessments, clinical practice and pharmacovigilance. As more complex synthetic products referencing recombinant originator products are expected in the coming years, this study promotes more transparency as well as global alignment about regulatory procedures for chemically synthesised products referencing biological originator products to ensure approval of safe and high-quality generics.

Keywords

EU, European landscape, European regulatory system, alignment, approval, article, assessment, biological origin, biosimilars, chemical, clinical practice, development, drug manufacturers, framework, generics, global alignment, hybrid, hybrid pathway, manufacturing, medicinal products, medicine, origin, original product, overview, pathway, peptide, pharmacovigilance, polypeptide, polypeptide products, practice, procedure, production, reference, reference medicine, regulatory approval, regulatory assessment, regulatory framework, regulatory procedures, regulatory system, review, study, synthetic peptides, synthetic polypeptides, synthetic products, system, transparency, years

Funders

  • Novo Nordisk (Denmark)

Data Provider: Digital Science