Biosimilar and Biological Products – Decode FDA’s New Guidelines
Are you a biosimilar/biologic product’s developer/manufacturer? Are you waiting for FDA’s latest stand on biosimilars or soon-to-be Biologics? Here it is. For the development of biosimilars and interchangeable biosimilars, on 11 December 2018, FDA released two new draft Q&A guidance documents under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The agency also proposed two other documents on the same topic and a rule intended to amend the definition of a biological product.