Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.
- 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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