The development and commercialization of biosimilars require 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 constantly 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, EU5, and Japan) are included in the section “Biosimilar Profiles.” These profiles include information about the biosimilar’s 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
  • Fulphila
  • Herceptin
  • Humira
  • Imraldi
  • Inflectra
  • Mvasi
  • Neulasta
  • Nivestim/Nivestym
  • Remicade
  • Remsima
  • Renflexis
  • Rituxan/MabThera
  • Rixathon/Riximyo
  • Truxima
  • Udenyca
  • Zarzio/Zarxio

Table of contents

  • Reference Brand Developer Strategies
    • Companies Most at Risk from Biosimilars
    • Percentage of Loss in Global Ethical Drug Sales of Leading Innovator Companies Most Affected by New Biosimilar Product Launches: 2019-2025
    • Development of Next-Generation Biologics
      • Range of Next-Generation Biologics
        • Next-Generation Formulations of Existing Products
        • Case Study: Roche's Reformulation of Key Oncology Biologics
      • Extent of Innovation Required
        • Case Study: AbbVie's Investment in Next-Generation Biologics and Small-Molecule Agents to Defend Against Biosimilars
        • Alexion's Investment in a Next-Generation Biologic for Soliris
    • Innovative Delivery Devices or Systems
      • Case Study: Amgen's Neulasta Onpro Kit
      • Case Studies: Collaborating with Medical Devices Companies
    • Gaining Approval for Orphan Indications
    • Leveraging Intellectual Property and Legal Protections
      • Preparing a Legal Strategy
      • Legal Defense Strategies Used in the United States
        • Case Study: AbbVie's U.S. Humira Defense Strategy
        • Case Study: Sanofi's Use of the Drug Price Competition and Patent Term Restoration Act to Protect Lantus from Biosimilar Competition
        • Case Study: Roche's U.S. Intellectual Property for Enbrel
    • Pricing as a Defense Strategy
      • Pricing Strategies for Reference-Product Sponsors
        • Leveraging Discrepancies Between Biosimilar and Brand Patient Shares Using Rebates
        • Case Study: Janssen's Exclusive Tender Win for Infliximab in New Zealand
      • Dual Pricing Strategies in Emerging Markets
        • Case Study: Roche's Dual Pricing Strategies
      • Authorized Generics
        • Authorized Generics
        • Case Studies: Authorized Generics Launched by Leading Insulin Developers
        • Case Study: Authorized Version of Nesp in Japan
    • Deal Making with Key Stakeholders
      • Case Study: Janssen's Defense of Remicade's Market Share in the United States
      • Case Studies: Exclusive Agreements Between Amgen and DaVita and Between Vifor Pharma and Fresenius
      • Innovative Performance-Based Risk-Sharing Schemes
    • Counter-Detailing and Value-Added Services
      • Counter-Detailing
      • Value-Added Services

Author(s): Jimmy Jacob; Marta Delgado, PhD

Jimmy Jacob, is a Business Insights Analyst in the Biosimilars team. Prior to joining DRG, Jimmy worked as a Scientist in Medimmune and Horizon Discovery mostly involving CRIPSR/Cas9 therapeutics. He received his master’s degree in Biotechnology from University of Dundee and his from Imperial College London. His work involved identifying novel molecules that regulated oestrogen receptor-alpha in breast cancer.

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.