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Biosimilars | Access & Reimbursement | Global Landscape | US | 2023

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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
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