Since the existence of a legal pathway for biosimilars was made possible by the signing of the 2009 Biologics Price Competition and Innovation (BPCI) Act in 2010 by President Barack Obama, FDA has declared itself ‘open for business’ for biosimilars . But what is the thinking of FDA and what should we expect from any guidance on biosimilars?
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- 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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