News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
dispatches from aaps
Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.
Bioinvent has been granted a US patent for its FIRST screening platform and says it is unique in selecting antibodies without any prior knowledge of target identities.
Genentech has recommissioned plans to make a Californian facility the largest biologics plant worldwide after anticipated revenue drop from biosimilars did not materialise.