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 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
  • Herceptin
  • Humira
  • Inflectra
  • Neulasta
  • Nivestim
  • Remicade
  • Renflexis
  • Remsima
  • Rituxan/MabThera
  • Truxima
  • Zarzio/Zarxio