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