FDA Advisory Panel Recommends Approval of Biosimilar Infliximab
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.
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FDA Advisory Panel Recommends Approval of Biosimilar Infliximab
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.
House Energy & Commerce Committee Holds Hearing on Biosimilars
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 […]
ASBM Participates in Brussels Labelling Workshop
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 […]
ASBM Submits Comments Supporting Biosimilars User Fee Act (BsUFA) Reauthorization
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 […]
Video: The Evolution of Biotechnology- The Arrival of Biosimilars
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.
Video: The Evolution of Biotechnology- The Arrival of Biosimilars
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.
ASBM Presents to Ontario Hospital Association
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 […]
Health Canada Releases New SEB/Biosimilar Guidance
December 8, 2015
On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian […]
Health Canada Releases New SEB/Biosimilar Guidance
December 8, 2015
On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian […]
