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 in different countries can be a significant challenge. The Access & Reimbursement Overview allows rapid assessment of key market access parameters across 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 product 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
  • 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
  • Herceptin
  • Humira
  • Inflectra
  • Neulasta
  • Nivestim
  • Remicade
  • Remsima
  • Rituxan/MabThera
  • Truxima
  • Zarzio/Zarxio