0
A consensus has emerged that approval of biosimilars requires both biological and clinical evidence. The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physico-chemical characterisation by several methods, comparative biological assays, comparative immunogenicity assessment, among others. The use of different host cells for the biosimilar product and the comparator in principle is possible.
- Home
-
Generics
News
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
-
Biosimilars
News
- FDA approves tocilizumab biosimilar Avtozma
- January 2025 biosimilar approvals in Europe
- EC approves eight biosimilars, eight more await final authorization
- Canada approves first omalizumab biosimilar Omlyclo
- MORE EDITORIAL SECTIONS
- Search
Post your comment