The US FDA asserts its full authority over biological product nonproprietary naming and justifies its final guidance requirement for distinguishable, nonmeaningful suffixes in a recent response to several industry citizen petitions.
A response to the Generic Pharmaceutical Association (GPhA), Sandoz Inc. and Johnson & Johnson lays out the statutory basis for the agency’s view that it alone has authority to designate the “proper name” for US-licensed biologic products, including reference products and biosimilars