Opportunities in an Evolving Pharmaceutical Development Landscape: Product Differentiation of Biopharmaceutical Drug Products

Pharm Res. 2021 May;38(5):739-757. doi: 10.1007/s11095-021-03037-5. Epub 2021 Apr 26.

Abstract

The current perspective reviews the biopharmaceutical market until end of 2020 and highlights the transforming biopharmaceutical landscape during the recent decade. In particular, the rise of biosimilars and the development of new therapeutic modalities through recent advancement in molecular biology research sustainably change the product scenery. The present manuscript describes opportunities for pharmaceutical technical development, highlighting concepts such as product differentiation to succeed in a competitive product landscape. Product differentiation offers the opportunity for numerous life-cycle options and market exclusivity through incremental improvements in standard of care treatment. In particular, different formulation options and formulation-device combinations are described, focusing on systemic delivery of monoclonal antibody products and patient-centered development. The concept of product differentiation is exemplified in a case study about HER2+ breast cancer therapy, underlining pharmaceutical technical solutions and major improvements for the patient.

Keywords: biosimilar; co-formulation; combination products; drug delivery; product differentiation.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Biological Products / pharmacology
  • Biological Products / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Disease-Free Survival
  • Drug Compounding / methods
  • Drug Compounding / trends
  • Drug Delivery Systems / methods
  • Drug Delivery Systems / trends
  • Drug Development / organization & administration
  • Drug Development / trends*
  • Drug Industry / organization & administration*
  • Drug Industry / trends
  • Female
  • Humans
  • Receptor, ErbB-2 / antagonists & inhibitors
  • Receptor, ErbB-2 / metabolism
  • Survival Rate

Substances

  • Antibodies, Monoclonal
  • Biological Products
  • ERBB2 protein, human
  • Receptor, ErbB-2