The US Food and Drug Administration (FDA) has released new guidance on submitting bioavailability information for drug products in investigational new drug applications (INDs) and new drug applications (NDAs).
- 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
- MORE EDITORIAL SECTIONS