Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 4
Abstract
Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently included in the World Health Organization Essential Medicines List. Given that peg-interferon is a biotechnological product, should low- to middle-income countries adopt the burdensome biosimilar approval pathway of western countries or should they find a more pragmatic approach, focusing on efficacy and safety to gain access to affordable biotechnological products?
Authors and Affiliations
Armando A Genazzani, Nicola Magrini
Keywords
Related Articles
- EP ID EP354628
- DOI 10.5639/gabij.2013.0204.044
- Views 110
- Downloads 0
Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions
Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low...
Italy’s final position paper on biosimilars and new price and reimbursement pathway
The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access.
Alleviating concerns around generic antiepileptic medications
Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because these have to be tak...
Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies
The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...
Biosimilarity in Latin America
The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these...