Biosimilars – Access & Reimbursement – Access & Reimbursement Global Landscape
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, 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, and China.
Key companies mentioned
- Amgen
- Biocon
- Boehringer Ingelheim
- Celltrion
- Eli Lilly
- Fresenius Kabi
- Hospira
- Merck & Co.
- Pfizer
- Roche
- Samsung Bioepis
- Sandoz
- Viatris
Key drugs mentioned
- Avastin
- Alymsys
- Aybintio
- Basaglar
- Benepali
- Binocrit
- Brenzys
- Byooviz
- Byvasda
- Enbrel
- Fulphila
- Herceptin
- Humira
- Inflectra
- Kanjinti
- Mvasi
- Neulasta
- Nepexto
- Nivestim
- Nyvepria
- Onbevzi
- Ongavia
- Releuko
- Remicade
- Renflexis
- Remsima
- Rianbi
- Rituxan/MabThera
- Ruxience
- Semglee
- Stimufend
- Truxima
- Udenyca
- Vegzelma
- Yuflyma
- Zarzio/Zarxio
- Zercepec
- Zirabev
Table of contents
- Biosimilars - Access & Reimbursement - Access & Reimbursement Global Landscape
- Executive Summary
- EU5
- Key Findings
- 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
- Discount Applied to the Reference Biologic and the Biosimilar, Based on the Observed Market Share of Reference Biologic
- 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
- Regulations and guidance
- Biological drug definition
- Bu200biosimilar 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 data extrapolation
- State-level legislation on biosimilar substitution
- State-level legislation requirements for biosimilar substitution
- Opportunities and incentives for interchangeable 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
- Reimbursement of biosimilars under Medicare Part D
- Reimbursement of biosimilars under Medicaid
- Reimbursement of biosimilars under the 340B program
- Strategies to drive uptake
- Canada
- Key findings
- Regulations and guidance
- Biological drug definition
- Biosimilar definition
- Scope of guidance
- Reference product requirements
- Nonproprietary naming
- Labeling
- Automatic substitution
- Different perspectives toward non-medical biosimilar substitution in Canada
- Pricing
- Reimbursement
- Provincial and territorial details on biosimilar switching and reimbursement
- Japan
- 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
- 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
- Brazil
- 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
- Australia
- 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
- Appendix
- Bibliography
- Abbreviation Table
- Executive Summary
Yashu Malhotra, M.Pharm., is an analyst on the Biosimilars and Oncology teams at Clarivate. Previously, she was a senior analyst in the life sciences department at Course5 Intelligence. She also worked in competitive intelligence at WNS Global Services. Ms. Malhotra earned her master’s degree in pharmacy (quality assurance) from India’s Delhi Institute of Pharmaceutical Sciences and Research.
Rashi Tiwari, Pharm.D., Associate Healthcare Research and Data Analyst, Biosimilars. Prior to joining Clarivate, Dr. Tiwari was a research associate in competitive intelligence at Vyuhgenics. She earned her doctorate in pharmacy from KLE College of Pharmacy in Belagavi, where she also interned as a clinical research coordinator at KLE’s Dr. Prabhakar Kore Hospital.