Patent Docs: European Medicines Agency Releases Paper on Biosimilar Medicines

Patent Docs: European Medicines Agency Releases Paper on Biosimilar Medicines: "In the paper, the EMEA defines a 'biological medicine' as a medicine whose active ingredient is made by or derived from a living organism (such as recombinant insulin produced by a bacterium carrying the insulin gene), a biological reference medicine' as an authorized biological medicine, and a 'biosimilar medicine' as a medicine that is similar to the biological reference medicine. In describing the similarity between a biological reference medicine and a biosimilar medicine, the EMEA noted that, in general, both would be used 'at the same dose to treat the same disease,' but that because the two 'are similar but not identical, the decision to treat a patient with a reference or a biosimilar medicine should be taken following the opinion of a qualified healthcare professional.'"