On June 24, 2017, Hogan Lovells attorneys Xin Tao (Washington DC Office) and Liang Xu (Beijing Office) spoke at the 15th Annual Conference of the Sino-American Pharmaceutical Professionals Associ...
On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)...
https://www.biosimilarslawblog.com/2017/06/13/supreme-court-issues-landmark-biosimilar-ruling/
The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and ...
The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial lett...
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a...
https://www.biosimilarslawblog.com/2016/06/23/aifa-publishes-second-concept-paper-on-biosimilars/
The Dutch Minister of Health (MoH) announced the set-up of a national system to trace the safety of biological medicinal products. The MoH expects an increase in the number of biosimilar prescri...
FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving pr...
In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed un...
In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio (filgrasti...
https://www.biosimilarslawblog.com/2015/07/08/abbvie-challenges-fda-biosimilar-labeling/
Five years after enactment of the BPCIA and following its first biosimilar approval, the U.S. Food and Drug Administration finalized its initial guidances describing the scientific and regulatory...
https://www.biosimilarslawblog.com/2015/06/23/fda-updates-u-s-biosimilar-guidances/