The regulatory and market access landscape for biosimilars is constantly evolving. For a company seeking to develop a biosimilar for multiple markets, keeping track of the similarities and differences between countries can be a significant challenge. The Access & Reimbursement Landscape allows rapid assessment of key market access parameters in the United States, EU5, Japan, Australia, Canada, and key emerging markets.

Questions answered

  • Does a dedicated biosimilar pathway exist in the country of interest?
  • What types of biological products fall within the scope of biosimilar guidance?
  • What are the regulatory considerations with regard to reference-product selection?
  • Is automatic pharmacy-level substitution permitted?
  • What pricing mechanisms exist for biosimilars and their reference products?
  • Is the local government actively driving biosimilar uptake?

Key markets covered

France, Germany, Italy, Spain, United Kingdom, United States, Japan, Australia, Brazil, Canada, China, India, Mexico, Russia, and South Korea.

Key companies mentioned

  • Amgen
  • Boehringer Ingelheim
  • Celltrion
  • Eli Lilly
  • Hospira
  • Merck & Co.
  • Mylan
  • Pfizer
  • Roche
  • Samsung Bioepis
  • Sandoz

Key drugs mentioned

  • Avastin
  • Basaglar
  • Benepali
  • Binocrit
  • Brenzys
  • Enbrel
  • Fulphila
  • Herceptin
  • Humira
  • Inflectra
  • Neulasta
  • Nivestim
  • Remicade
  • Renflexis
  • Remsima
  • Rituxan/MabThera
  • Truxima
  • Udenyca
  • Zarzio/Zarxio

Table of contents

  • Biosimilars - Access & Reimbursement - Access & Reimbursement Global Landscape
    • Key Findings
      • Global Biosimilar Pathways and Clinical Development Activity
    • EU5
      • Key Findings
      • Biosimilars Available in the EU
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • EMA Overarching Biosimilar Guidelines
        • EMA Product-Specific Biosimilar Guidelines
        • Quality
        • Nonclinical Studies
        • Clinical Studies
        • Safety and Pharmacovigilance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
        • France
        • ANSM List of Similar Biological Drug Products
        • Germany
        • Bioidenticals in Germany
        • Italy
        • Spain
        • United Kingdom
      • Pricing
        • France
        • ASMR Ratings and Pricing Implications in France
        • Germany
        • Italy
        • Spain
        • United Kingdom
      • Reimbursement
        • France
        • Germany
        • Italy
        • Spain
        • National Institute for Health and Care Excellence
        • Scottish Medicines Consortium
        • All Wales Medicines Strategy Group
      • Strategies to Drive Uptake
        • EU Market
        • France
        • Germany
        • German National Prescribing Quotas for Biosimilars
        • Italy
        • Spain
        • United Kingdom
    • United States
      • Key Findings
      • Biosimilars Available in the United States
      • Regulations and Guidance
        • Biological Drug Definition
        • B​iosimilar Definition
        • Drug Approval Pathways
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
        • Reauthorization of the Biosimilar User Fee Act
        • Biosimilar User Fee Act Fees
      • Automatic Substitution
        • Introduction
        • Overview of FDA Guidance on Interchangeability
        • Considerations for the Design and Analysis of Switching Studies
        • Considerations for Extrapolation of Data
        • State-Level Legislation on Biosimilar Substitution
        • State-Level Legislation Requirements for Biosimilar Substitution
        • Opportunities and Incentives for Biosimilar Sponsors
        • Risks for Biosimilar Sponsors
      • Pricing
        • WAC Discounts of the Biosimilars Available in the United States
      • Reimbursement
        • Reimbursement of Biosimilars Under Medicare Part B
        • HCPCS Code for Currently Available Biosimilars
        • Medicare Part B Reimbursement Scenarios
        • Scenario 1: Reimbursement of Biosimilars Until December 31, 2017
        • Scenario 2: Reimbursement of Biosimilars Starting on January 1, 2018
        • Reimbursement of Biosimilars Under Medicare Part D
        • Reimbursement of Biosimilars Under Medicaid
        • Reimbursement of Biosimilars Under the 340B Program
      • Strategies to Drive Uptake
    • Japan
      • Key Findings
      • Biosimilars Available in Japan
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Australia
      • Key Findings
      • Biosimilars Available in Australia
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Brazil
      • Key Findings
      • Non-Innovator Biologics Available in Brazil
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Canada
      • Key Findings
      • Biosimilars Available in Canada
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Inclusion of Biosimilars on Provincial Formularies
    • China
      • Key Findings
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • India
      • Key Findings
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Mexico
      • Key Findings
      • Biosimilars Available in Mexico
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Russia
      • Key Findings
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Naming
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • South Korea
      • Key Findings
      • Biosimilars Available in South Korea
      • Regulations and Guidance
        • Biological Drug Definition
        • Biosimilar Definition
        • Scope of Guidance
        • Reference Product Requirements
        • Nonproprietary Name
        • Labeling
      • Automatic Substitution
      • Pricing
      • Reimbursement
      • Strategies to Drive Uptake
    • Appendix
      • Bibliography
      • Abbreviations

Author(s): Marta Delgado; Hamzah Aideed, M.Sc.

Marta Delgado, Ph.D. 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 Ph.D. in Molecular Neuroscience from University College of London (UCL) and a B.Sc. 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.

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.