FDA Approves Fresenius Kabi Biosimilar for Neulasta®

By Kevin E. Noonan — It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs (see "Trump Administration Considering Reduction in Biologics Exclusivity Period; A Solution in Search of a Problem"; "FDA Issues Plan for Further Facilitating Biosimilar Development"; "Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement"; "Biosimilars Action Plan: Balancing Innovation and Competition"; "Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term"). These sentiments were largely from outcome-oriented groups with little understanding or regard for process or…