In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.
- 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
- Biosimilar regulations perspective in Latin America to improve cancer treatment access
- Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta
- Therapeutic drug monitoring with infliximab improves disease control
- WHO revised guidelines for biosimilars: scientific background
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