Biosimilars | Access & Reimbursement | Global | 2017
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
