Ray Patnaude – Page 14 – Safe Biologics

ASBM Meets with Health Canada, FDA, WHO on Biologic Nomenclature Harmonization

March 7, 2019

On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated. The meeting began with opening remarks by ASBM Executive Director Michael Reilly […]

ASBM Chair Discusses Interchangeability, Need for Education

March 2, 2019

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey. Clips from the interview […]

ASBM Advisory Board Chair Responds to Mischaracterization of Comments in Washington Post

January 14, 2019

by Philip Schneider, MS FASHP FFIP Advisory Board Chair, Alliance for Safe Biologic Medicines This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post. My comments that were misinterpreted in this article […]

November-December 2018 Newsletter

December 1, 2018

newsletter | November-December 2018 issue 72 Who We Are The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission […]

GaBI Journal: Benefits of WHO’s BQ Proposal to Middle Eastern Countries; co-authored by ASBM’s Michael Reilly

November 14, 2018

On November 2nd, 2018, the GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier”. The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would […]

October 2018 Newsletter

November 1, 2018

newsletter | October 2018 issue 70 Who We Are The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It […]

Non-Medical Switching: What do Physicians and Patients Think?

October 5, 2018

Three physicians and two patient advocates discuss their concerns with the non-medical switching of biologic medicines by third parties such as insurers or pharmacy-benefit managers (PBMs). ASBM’s Chair, Madelaine Feldman, MD FACR is joined by ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; and ASBM’s Founding Chair, Richard Dolinar, MD; to discuss physician perspectives on NMS. The patient […]

ASBM Submits Comments to FDA on Biosimilars

September 27, 2018

On September 21st, 2018 ASBM submitted comments to FDA as a follow-up to September 4th Public Hearing “Facilitating Competition and Innovation in the Biological Products Marketplace”, at which three ASBM Chairs, and several Steering Committee members testified. The purpose of the hearing and the request for comments, is to seek input on how the FDA can achieve the following goals: […]

Canadian Biosimilar Working Group Launches Website

September 14, 2018

The Biosimilar Working Group, a Canadian-based coalition of non-profit organizations, registered health charities, and health care advocacy coalitions, launched its website this month. The launch was announced in conjunction with the Group’s September meeting in Toronto, ON. The Biosimilars Working Group is dedicated to ensuring that good outcomes for patients are at the centre of health […]

ASBM Chairs Past and Present, Four Steering Committee Members Testify at FDA Biosimilar Hearing

September 13, 2018

On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition: Improving the efficiency of the biosimilar and interchangeable product development and approval process Maximizing scientific and regulatory clarity […]