Biosimilars and Biologics

In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve Biosimilars to those biologics originally approved through the PHS Act pathway. Since 2004 the FDA has held a series of public meetings on Biosimilars. The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin originally approved as a biologic drug under the FD&C Act.