The increasingly globalized nature of commerce allows manufacturers to outsource activities, such as procurement of raw materials overseas, where different regulatory requirements may exist. Thus, there is a need to ensure that the good manufacturing practices (GMP) guidelines adopted by the regulatory authorities (RAs) and international organizations (IOs) are harmonized and robust. A robust set of GMP guidelines helps in safeguarding public health by assuring the quality, safety and efficacy of the biopharmaceuticals .
- 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
- MORE EDITORIAL SECTIONS