0
Biosimilars or follow-on biologics (FOBs) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FOBs require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FOB marketing approval are not feasible.
- 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
- EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec
- EMA recommends approval for teriparatide biosimilar Zandoriah
- FDA approves third interchangeable ranibizumab biosimilar Nufymco
- FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars
Research
- OECD study finds no direct link between advertising rules and biosimilar uptake
- Reaching ESG goals in pharmaceutical development
- What is the future for the US biosimilar interchangeability designation
- Biosimilar clinical efficacy studies: are they still necessary?
- MORE EDITORIAL SECTIONS
- Search
Post your comment