… to biotherapeutics was applauded by participants and … comparator products and impact on
biosimilar medicines. Post-… ’ held at the CASSS CMC Strategy Forum earlier this year from the …

… , specialty drug approvals by the Food and Drug Administration (… This has been supported
by education campaigns, … fit very well into the idea of improving value and reducing cost. After …

… disputes between biologic drug innovators and manufacturers of biosimilar drugs. The names
… its opinion that each patent will be infringed by the commercial marketing of the biosimilar. …

… “GPhA applauds efforts in Georgia to foster timely access to … improve physician awareness
and education, a necessary … Health Industry Forum lauded the advancement of a biosimilar …

… I applaud the Law Review for making publication of this … Federal Circuit also provides a
forum that will increase doctrinal … pathways for generic and biosimilar medicines, this Article …

… The committee commends this plan and encourages the … Regulators Forum, was founded
in 2011 to promote regulatory … not entirely transferable to biosimilars, but an unnecessarily …

… The committee commends this plan and encourages the … Regulators Forum, was founded
in 2011 to promote regulatory … not entirely transferable to biosimilars, but an unnecessarily …

… in a recent Food and Drug Law Institute Policy Forum. Tracking … is part of the transition into
the biosimilar user fee program. … The move was widely applauded by food safety advocates, …

… new ideas of my own. While I applaud the SPERT recommendation of the PSAP (Program …
assessment committee appear in the literature (US Food and Drug Administration 2015a). …

… Medicines Agency (EMA) itself emphasizes that “medicines … The education and professional
status of pharmacists was … /hybrid/biosimilar) initial marketing authorization applications with …