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

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 is a Principal Analyst in the biosimilars team at Decision Resources Group. Hamzah’s responsibilities include conducting primary and secondary market research, generating key insights into biosimilars and the biopharmaceutical industry, and providing client support. His work in biosimilars encompasses four key therapy areas – immunology, oncology, endocrinology, and nephrology.

Prior to joining DRG, Hamzah was a Senior Research Executive at 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 & Business Management from the University of Warwick and a B.Sc. in Biological Chemistry from Aston University.