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
Related Market Assessment Reports
Report
Uterine Fibroids – Current Treatment – Treatment Algorithms: Claims Data Analysis – Uterine Fibroids (US)
Treatment for uterine fibroids includes pharmacological approaches and surgical procedures. NSAIDs help alleviate the pain but do not reduce the fibroids’ size. Progestins (e.g., norethindrone,…
Report
Irritable Bowel Syndrome – Current Treatment – Treatment Algorithms: Claims Data Analysis – IBS-Constipation (Including IBS Without Diarrhea) (US)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by alterations in motility, stool consistency and frequency, and urgency. It is classified into three subtypes:…
Report
Kidney Transplant – Current Treatment – Treatment Algorithms: Claims Data Analysis – Kidney Transplant (US)
Each year in the United States, thousands of patients with end-stage renal disease undergo a kidney transplant. To prevent rejection and maintain the new kidney’s functionality, patients must…
