| True generics for biologics are not possible, so the term biosimilars were created creating an approval process for them. (Zarxio, biosimilar for Neupogen was the frsrt approved in 2015). | |
| mandated accurate product labeling with standards of strength, quality and purity. | |
| The Omnibus Budget Reconciliation Act of 1990 | |
| Expedited and streamlined generic drug approvals via an ANDA or 505b2 |