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

Key drugs mentioned:

  • Abasaglar/Basaglar
  • Abseamed
  • Accofil
  • Amjevita/Amgevita
  • Avastin
  • Avsola
  • Aybintio
  • Benepali
  • Binocrit
  • Cyltezo
  • Enbrel
  • Epoetin alfa Hexal
  • Erelzi
  • Flixabi
  • Fulphila
  • Hadlima
  • Herceptin
  • Herzuma
  • Humira
  • Hulio
  • Hyrimoz
  • Idacio
  • Imraldi
  • Inflectra
  • Insulin Lispro Sanofi
  • Kanjinti
  • Mvasi
  • Neulasta
  • Nivestim/Nivestym
  • Ogivri
  • Ontruzant
  • Pelmeg
  • Pelgraz
  • Remicade
  • Remsima
  • Renflexis
  • Retacrit
  • Rituxan/MabThera
  • Rixathon/Riximyo
  • Ruxience
  • Semglee
  • Silapo
  • Trazimera
  • Truxima
  • Udenyca
  • Zarzio/Zarxio
  • Zessly
  • Ziextenzo
  • Zirabev

Table of contents

  • Biosimilars - Corporate Strategies - 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: 2020-2026
    • 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
        • SWOT Analysis of SC Formulations of Rituxan/MabThera and Herceptin as a Defense Strategy for Roche
      • Extent of Innovation Required
        • AbbVie’s Investment in Next-Generation Biologics and Small-Molecule Agents to Defend Against Biosimilars
        • AbbVie’s Investment in Next-Generation Biologics and Small-Molecule Agents
        • Sales Forecast for AbbVie's Immune Franchise
        • AbbVie's Immune Franchise Sales Forecast: 2019-2026
    • Innovative Delivery Devices or Systems
      • Case Study: Amgen’s Neulasta Onpro Kit
      • Case Studies: Collaborating with Medical Device Companies
    • Gaining Approval for Orphan Indications
      • Biologics That Have Secured Orphan Drug Designation to Maintain Revenue in the United States
    • 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
        • U.S. Launch Dates of Adalimumab Biosimilars
        • 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: Amgen's Defense of Enbrel's Intellectual Property in the United States
    • Pricing as a Defense Strategy
      • Pricing Strategies for Reference-Product Sponsors
        • Leveraging Discrepancies Between Biosimilar and Brand Patient Shares Using Rebates
        • Example: Hypothetical Rebate Negotiations
        • 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
        • Case Studies: Authorized Generics Launched by Eli Lilly and Novo Nordisk
        • Case Study: Authorized Version of Nesp in Japan
      • Subscription Pricing Models
        • Sanofi’s Insulins Valyou Savings Program
        • Novo Nordisk's My$99Insulin Program
    • Deal Making with Key Stakeholders
      • Case Study: Johnson & Johnson Defense of Remicade's Market Share in the United States
      • Case Studies: Exclusive Agreements Between Amgen and DaVita and Vifor Pharma and Fresenius
      • Innovative Performance-Based Risk-Sharing Schemes
    • Counterdetailing and Value-Added Services
      • Counterdetailing
      • Value-Added Services

Author(s): Hamzah Aideed, M.Sc.

Hamzah Aideed, M.Sc., is a principal analyst on the Biosimilars team at DRG, part of Clarivate. He conducts primary and secondary market research to provide in-depth analysis and insight into the biopharmaceutical industry. Prior to joining DRG, Mr. Aideed was a senior research executive in 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 M.Sc. in biotechnology, bioprocessing, and business management from the University of Warwick and a B.Sc. in biological chemistry from Aston University in Birmingham.