The development and commercialization of biosimilars require a significant investment in capital, resources, and time. Biosimilar developers must ensure that they are equipped with the necessary expertise in development and manufacturing capabilities. With the number of approved biosimilars ever increasing, the biopharmaceutical space is set to become more competitive for both innovator and biosimilar companies. As such, it is paramount that biosimilar and innovator companies have well-defined strategies to maximize their competitiveness. In this content, we assess strategies—based on actual practices—that companies can use to flourish in competitive global markets.

The product profiles of the biosimilars that have launched or will soon enter the major markets (United States, EU and Japan) are included in the section “Biosimilar Profiles”. These profiles include information about the biosimilar developer(s) and marketer(s), regulatory timelines, development history, approved indications, summary of clinical development, and position in the market.

Questions answered in this report:

  • How have biosimilar developers achieved success in the biosimilars market?
  • What options are available to biosimilar developers that lack in-house manufacturing capabilities?
  • What factors should biosimilar developers consider when designing biosimilar clinical programs?
  • How can biosimilar and reference-brand companies exploit the multifactorial decision-making process used by stakeholders to differentiate their product from the competition?
  • What types of data do physicians require to increase their use of biosimilars in biologic-treated patients?
  • What options are available to reference-brand companies seeking to defend against biosimilar entry?

Key markets covered:

  • Global

Key companies mentioned:

  • AbbVie
  • Amgen
  • Biocon
  • Biogen
  • Boehringer Ingelheim
  • Celltrion
  • Coherus Biosciences
  • Eli Lilly
  • Halozyme
  • Hospira
  • Merck & Co.
  • Mylan
  • Novartis
  • Pfizer
  • Roche
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • Teva

Key drugs mentioned:

  • Abasaglar/Basaglar
  • Amjevita/Amgevita/Solymbic
  • Avastin
  • Benepali
  • Binocrit
  • Cyltezo
  • Enbrel
  • Erelzi
  • Flixabi
  • Herceptin
  • Humira
  • Imraldi
  • Inflectra
  • Mvasi
  • Neulasta
  • Nivestim
  • Remicade
  • Remsima
  • Renflexis
  • Rituxan/MabThera
  • Rixathon/Riximyo
  • Truxima
  • Zarzio/Zarxio

Table of contents

  • Appendix
    • Bibliography
    • Sources for Drug Prices
    • Table of Abbreviations

Author(s): Hamzah Aideed, MSc; Marta Delgado, PhD

Hamzah Aideed is a Principal Analyst in the biosimilars team at Decision Resources Group. Hamzah’s responsibilities include conducting primary and secondary market research, generating key insights into biosimilars and the biopharmaceutical industry, and providing client support. His work in biosimilars encompasses four key therapy areas – immunology, oncology, endocrinology, and nephrology. Prior to joining DRG, Hamzah was a Senior Research Executive at Consulting at McCann Health, specializing in the design and execution of advanced qualitative and quantitative research methodologies, for bespoke ad-hoc consulting projects. He holds an in Biotechnology & Business Management from the University of Warwick and a in Biological Chemistry from Aston University.  

Marta Delgado, is a Business Insight Analyst in the Biosimilars Research team, responsible for the analysis of the biosimilars market across four main therapeutic areas – oncology, endocrinology, immunology and nephrology. Marta holds a in Molecular Neuroscience from University College of London (UCL) and a in Biomedicine from University Pompeu Fabra (UPF), Barcelona. Prior to joining the Biosimilars Research team, Marta worked as a Research Analyst at SKIM, specialising in advanced quantitative studies assessing the potential market opportunities to support life sciences companies in their business decision making.