Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US . So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
- Relevance of NTI to the treatment of epilepsy
- What is the meaning of a narrow therapeutic index?
- Consequences of generics being favoured by healthcare providers
- What is meant by a generic medication and generic equivalence?
- Innovent-Etana bevacizumab biosimilar approved in Indonesia
- Ranibizumab biosimilar, FYB201, receives EMA recommendation
- New data on infliximab and adalimumab biosimilars at EULAR 2022
- EMA accepts application for high concentration adalimumab biosimilar
- Perspectiva de la regulación de biosimilares en América Latina para mejorar el acceso al tratamiento del cáncer
- Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta
- Therapeutic drug monitoring with infliximab improves disease control
- Directrices revisadas de la OMS para los biosimilares: antecedentes científicos
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