Inflectra (infliximab-dyyb), Pfizer/Celltrion’s Remicade biosimilar, became the first monoclonal antibody biosimilar to enter the U.S. market in late November 2016. Merck & Co.’s Renflexis (infliximab-abda) subsequently launched in July 2017. Waves 1 and 2 of this series track Inflectra’s awareness and uptake since launch, while Wave 3 also incorporates Renflexis. Along with awareness, familiarity, and perceptions of biosimilars, our research explores the drivers and barriers behind uptake of both Inflectra and Renflexis. Promotional efforts are also explored, as well as prescriber and nonprescriber profiles, and benchmarking comparisons against other available biosimilars, to better understand the dynamics of the U.S. biosimilars market.

Questions Answered

  •  Are U.S. physicians aware of Inflectra and Renflexis?
  • What are the drivers to prescribing an infliximab biosimilar? What is the level of Inflectra and Renflexis use, and how is that changing over time?
  • Are physicians’ opinions of biosimilars changing?
  • Have physicians experienced pressures to prescribe Inflectra or Renflexis to patients?
  • What promotional messages are sales representatives employing for Inflectra, Renflexis, and Remicade?
  • How does formulary placement of Inflectra and Renflexis compare with Remicade, and does this change over time?

Scope:

  • Markets covered: United States.
  • Primary research: Survey of 92 U.S. rheumatologists, gastroenterologists, and dermatologists.

Key Companies Mentioned:

  • Celltrion.
  • Johnson & Johnson/Janssen.
  • Merck & Co.
  • Pfizer.
  • Samsung Bioepis.

Key Drugs Mentioned:

  • Remicade (infliximab).
  • Inflectra (infliximab-dyyb).
  • Renflexis (infliximab-abda).
  • Enbrel (etanercept).
  • Humira (adalimumab).

Table of contents

  • Biosimilars - Emerging Biosimilars - Immunology: Inflectra/Renflexis Launch Tracking (US) Wave 3
    • Key Findings
      • Biosimilar Prescriber and Nonprescriber Profiles
        • Differences Between Inflectra or Renflexis Prescribers and Nonprescribers
        • Significant Differences Between Inflectra Prescribers and Nonprescribers
        • Significant Differences Between Renflexis Prescribers and Nonprescribers
    • Benchmarking the Launch Success of Inflectra and Renflexis vs. Other Biosimilars Launches
      • Inflectra and Other Biosimilars Launch Metrics
      • Renflexis and Other Biosimilars Launch Metrics
    • Formulary Analysis
      • Formulary Coverage of Inflectra and Renflexis Versus Remicade
        • Formulary Coverage of Infliximab
        • Remicade, Inflectra, and Renflexis Coverage Among Commercial Plans
        • Remicade, Inflectra, and Renflexis Coverage Among Medicare Plans
        • Commercial and Medicare Plan Coverage for Inflectra and Renflexis Compared with Remicade
        • Changes in Formulary Status Between January and October 2017
    • Awareness and Perceptions of Inflectra and Renflexis
      • Awareness and Familiarity with Inflectra and Renflexis
        • Biologics Recalled for Rheumatoid Arthritis
        • Biologics Recalled for Crohn's Disease
        • Biologics Recalled for Ulcerative Colitis
        • Biologics Recalled for Plaque Psoriasis
        • Level of Familiarity with Biosimilars
        • Mean Level of Familiarity with Biosimilars
        • Mean Level of Familiarity with Inflectra
        • Level of Familiarity with Inflectra
        • Mean Level of Familiarity with Renflexis
        • Level of Familiarity with Renflexis
      • Perceptions of Inflectra and Renflexis
        • Physicians' Perception of Inflectra and Renflexis for Tested and Approved Indications
        • Indications in Which Physicians Believe Inflectra Was Clinically Studied Prior to Approval
        • Indications in Which Physicians Believe Renflexis Was Clinically Studied Prior to Approval
        • Indications in Which Physicians Believe Inflectra Is Approved for Treatment
        • Indications in Which Physicians Believe Renflexis Is Approved for Treatment
        • Indications in Which Physicians Believe Inflectra Should Be Approved for Treatment
        • Indications in Which Physicians Believe Renflexis Should Be Approved for Treatment
        • Physicians' Perceived Importance of European Postmarketing Experience for Inflectra and Renflexis
        • Importance of European Postmarketing Experience for Inflectra's Approved Indications in the United States
    • Trial and Use
      • Current Use of Inflectra or Renflexis
        • Prescribers of Inflectra
        • Prescribers of Renflexis
        • Prescribers of Inflectra and Renflexis
        • The Number of Patients Who Have Received Inflectra
        • The Number of Patients Who Have Received Renflexis
        • Healthcare Coverage of Patients by Indication
        • Healthcare Coverage of Inflectra-Treated Patients
        • Healthcare Coverage of Renflexis-Treated Patients
        • Percentage of Inflectra-Treated Patients Who Were Biologic-Naive or Switched from Another Biologic
        • Current Patient Share for Rheumatoid Arthritis
        • Current Patient Share for Crohn's Disease
        • Current Patient Share for Plaque Psoriasis
      • Drivers of and Barriers to Inflectra or Renflexis Use
        • Reasons for Choosing to Prescribe Inflectra
        • Factors Influencing the Choice of Two Marketed Infliximab Biosimilars
        • Percentage of Physicians Who Report That Inflectra Is Unavailable to Them
        • Percentage of Physicians Who Report That Renflexis Is Unavailable to Them
        • Reasons for Not Prescribing Inflectra
        • Reasons for Not Prescribing Renflexis
        • Percentage of Physicians Who Are Unaware of Inflectra's Net Cost Compared with Remicade
        • Percentage of Physicians Who Are Unaware of Net Cost of Renflexis Compared with Remicade
        • Mean Physician-Reported Net Cost of Remicade After Launch of Infliximab Biosimilars
        • Mean Physician-Reported Net Cost of Inflectra Below Remicade
        • Mean Physician-Reported Net Cost of Renflexis Below Remicade
        • Prescribers' Perception of Inflectra's Similarity to Remicade
        • Prescribers' Perception of Renflexis's Similarity to Remicade
        • Mean Level of Satisfaction with Inflectra
        • Mean Level of Satisfaction with Renflexis
        • Overall Level of Satisfaction with Inflectra
        • Overall Level of Satisfaction with Renflexis
    • External Factors Affecting Use
      • Sources of Pressure or Recommendations to Use Inflectra or Renflexis
        • Sources of Pressure for the Use of Inflectra or Renflexis Instead of Remicade
        • Sources of Pressure for the Use of Inflectra Instead of Remicade: Prescribers and Nonprescribers
        • Sources of Pressure for the Use of Renflexis Instead of Remicade: Prescribers and Nonprescribers
        • Types of Pressure Experienced by Physicians to Use Inflectra or Renflexis
        • Types of Pressure Experienced for the Use of Inflectra and Renflexis
        • Types of Pressure Experienced for the Use of Inflectra: Prescribers and Nonprescribers
        • Types of Pressure Experienced for the Use of Renflexis: Prescribers and Nonprescribers
      • Patients' Acceptance of Inflectra
        • Percentage of Physicians Who Have Never Proposed Inflectra to Their Patients
        • Mean Percentage of Patients Who Have Accepted Inflectra
    • Promotional Activity
      • Promotional Activity for Inflectra or Renflexis vs. Remicade
        • Physicians' Most Recent Contact with Remicade's Medical Representatives
        • Physicians' Most Recent Contact with Inflectra's Medical Representatives
        • Physicians' Most Recent Contact with Renflexis's Medical Representatives
        • Topics Discussed with Medical Representatives of Remicade
        • Topics Discussed with Medical Representatives of Inflectra
        • Topics Discussed with Medical Representatives of Renflexis
    • Future Use of Biosimilars
      • Willingness to Prescribe Novel Biosimilars
        • Rheumatologists' Likelihood of Prescribing Other Biosimilars as a Result of Inflectra and Renflexis Use
        • Gastroenterologists' Likelihood of Prescribing Other Biosimilars as a Result of Inflectra and Renflexis Use
        • Dermatologists' Likelihood of Prescribing Other Biosimilars as a Result of Inflectra and Renflexis Use
        • Mean Likelihood of Prescribing Other Infliximab Biosimilars
        • Rheumatologists' Likelihood of Prescribing Other Infliximab Biosimilars
        • Gastroenterologists' Likelihood of Prescribing Other Infliximab Biosimilars
        • Dermatologists' Likelihood of Prescribing Other Infliximab Biosimilars
        • Expected Length of Time to Start Prescribing Inflectra
        • Expected Length of Time to Start Prescribing Renflexis
        • Reasons Why Physicians Do Not Plan on Using Inflectra
        • Reasons Why Physicians Do Not Plan on Using Renflexis
        • Factors That Would Encourage Physicians to Initiate or Increase Inflectra Use
        • Factors That Would Encourage Physicians to Initiate or Increase Inflectra Use: Prescribers and Nonprescribers
        • Factors That Would Encourage Physicians to Initiate or Increase Renflexis Use
        • Factors That Would Encourage Physicians to Initiate or Increase Renflexis Use: Prescribers and Nonprescribers
      • Future Patient Share Expectations for Infliximab and Other Biologics
        • Expected Future Rheumatoid Arthritis Patient Share
        • Expected Future Crohn's Disease Patient Share
        • Expected Future Plaque Psoriasis Patient Share
        • Expected Impact of Patient Healthcare Coverage on Inflectra and Renflexis Uptake
        • Physicians' Expectation of Impact of Patients' Healthcare Coverage on Inflectra Uptake
        • Physicians' Expectation of Impact of Patients' Healthcare Coverage on Uptake of Renflexis
        • Reasons Why Physicians Think Inflectra’s Uptake Will Be Most Rapid Among Patients on Commercial Plans
        • Reasons Why Physicians Think Inflectra’s Uptake Will Be Most Rapid Among Patients on Government Plans
        • Reasons Why Physicians Think Uptake of Renflexis Will Be Most Rapid Among Patients on Commercial Plans
        • Reasons Why Physicians Think Uptake of Renflexis Will Be Most Rapid Among Patients on Government Plans
    • Appendix
      • Background on the U.S. Infliximab Market
        • Product Information: Remicade, Inflectra, and Renflexis
        • List Price for Infliximab
        • Market Background: Celltrion's and Samsung Bioepis' Partners for Infliximab Biosimilars
        • The Celltrion Partnership Network
        • Timeline of Milestones for Inflectra
        • Timeline of Milestones for Renflexis
        • Biologics Approved for Rheumatic, Inflammatory Bowel, and Psoriatic Diseases in the United States
        • Assumptions Supporting U.S. Launch Date Estimates for Future Infliximab Biosimilars
        • U.S. Launch Date Estimates for Future Infliximab Biosimilars
        • Clinical Trial Information in Which Inflectra Was Studied Prior to FDA Approval
        • Clinical Trial Information in Which Renflexis Was Studied Prior to FDA Approval
      • Market News
        • Methodology and Objectives
          • Objectives
          • Methodology
          • Number of Study Participants
          • Significance Testing in This Study
        • Respondent Demographics
          • Physicians' Primary Specialty
          • Mean Number of Years in Practice
          • Number of Years in Practice
          • Practice Type
          • Practice Location
          • Distribution of Respondents by Region
          • Number of Adult Patients Under Management per Month
          • Number of Pediatric Patients Under Management per Month
          • Available Biologics Prescribed for Rheumatoid Arthritis by Rheumatologists
          • Available Biologics Prescribed for Psoriatic Arthritis by Rheumatologists
          • Types of Patients Treated by Gastroenterologists
          • Available Biologics Prescribed for Crohn's Disease by Gastroenterologists
          • Available Biologics Prescribed for Ulcerative Colitis by Gastroenterologists
          • Available Biologics Prescribed for Psoriasis by Dermatologists

    Author(s): Jimmy Jacob

    Jimmy Jacob, Ph.D. 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 Ph.D. from Imperial College London. His Ph.D. work involved identifying novel molecules that regulated oestrogen receptor-alpha in breast cancer.