February 16, 2016
On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.
February 16, 2016
On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.
February 10, 2016
On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.
February 10, 2016
On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.
February 5, 2016
On February 4, the House Energy and Commerce Health Subcommittee held a hearing to discuss implementation of the Biologics Price Competition and Innovation Act (BPCIA). Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS), and Janet Woodcock, the Director of the Center for […]
February 3, 2016
On February 2nd, ASBM’s Chairman Harry Gewanter and its Executive Director Michael Reilly participated in a panel discussion in Brussels, Belgium. The panel was held as part of a Labelling Workshop hosted by the European Biopharmaceutical Enterprises (EBE) and EuropaBio. Dr. Gewanter and Mr. Reilly discussed the findings of ASBM’s surveys of U.S. physicians and […]
January 20, 2016
On January 19th, ASBM submitted comments to the FDA supportive of reauthorizing the Biosimilars User Fee Act (BsUFA) which funds the FDA’s biosimilar program through fees paid by biosimilar sponsors: “ASBM supports reauthorization of BsUFA because the FDA must always have adequate funding and resources to bring these medicines to patients both safely and in […]
December 14, 2015
This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.
December 14, 2015
This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.
December 9, 2015
On December 9th in Toronto, ON, ASBM Executive Director Michael Reilly gave a presentation entitled “Biosimilars: On the Forefront of Medical Innovation” as part of a webinar hosted by the Ontario Hospital Association (OHA). The OHA is a leader on the issue of patient safety in Canada and represents 151 hospitals. Prior to the presentation, a […]
