BLG 699 Lecture Notes - Lecture 4: Biosimilar, Lifesaving, Erythropoietin
Document Summary
Is subject to licensure under the public health service act. Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Human blood and plasma and their derivatives, and certain products produced by biotechnology, such as interferons and erythropoietin. Protein-based drugs, and include blood products such as clotting factors extracted from blood. Mimics / copycats of patented drugs and biologics. Process of mimicking regular biologics take more than 10 years. Are more accessible and cheaper than regular biogenics. 2012-19 will mark the golden period for biosimilar development, mimics of patent expiring blockbuster biologics. Products worth over billion in annual sales will be coming off patent. Companies looking to create biosimilar versions will jump in to create generic versions of these biologics that will be losing its patency.
