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.
Margaret McCarthy
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 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.
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 […]
ASBM Presents to Canadian Patient Advocates
November 20, 2015
On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. ASBM Executive Director Michael Reilly joined a patient […]
Governor Christie Signs NJ Biosimilars Bill
November 14, 2015
Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 […]
ASBM Argues for Distinguishable Naming at World Biosimilar Congress: Europe 2015
November 10, 2015
On November 10th, 2015 in Basel, Switzerland, ASBM’s Advisory Board Chair, University of Arizona pharmacy professor Philip J Schneider and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, participated in a debate on the subject of distinguishable naming for biosimilars. The debate session, entitled “Naming conventions for biosimilar and […]
ASBM Presents Latin American Survey Data in Brazil
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was […]
