EuropaBio Welcomes New EMEA Technical Document On Biosimilars
July 30th, 2007 by 
Barry - Admin BioPharmArena
The European biotechnology industry welcomes the European Medicines Agency’s (EMEA) new guidance on biosimilar medicines, entitled “Questions and Answers on biosimilar medicines” which was announced recently.
This initiative reinforces the EMEA communication on “biosimilar” medicine and recognises the uniqueness of these products. It states that they cannot be classified as “generics” in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.
Posted in Regulatory Affairs, Quality Assurance | 