May 15, 2018
On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce […]
April 12, 2018
On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]
April 1, 2018
Philip J. Schneider, MS FASHP ASBM Advisory Board Chair This week, West Virginia Governor Jim Justice and Wisconsin Governor Scott Walker signed bills updating pharmacy regulations in their respective states. The new laws permit pharmacists to substitute interchangeable biosimilars in place of an originator biologic medicine when they are approved by the FDA. The signing […]
February 10, 2018
On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored […]
February 8, 2018
For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]
February 2, 2018
On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance. Mr. Azar previously spent four years as the Department’s […]
January 26, 2018
On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World […]
January 12, 2018
On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines. “We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments […]
December 25, 2017
On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety. In the […]
December 7, 2017
The Alliance for Safe Biologic Medicines conducts regular surveys to better understand physicians’ perspectives on originator biologics and biosimilars. The organization recently released its 2017 Canadian Prescriber Survey. The survey reveals Canadian physicians’ attitudes on a number of critical policy issues surrounding the approval and use of originator biologics and biosimilars. 83 per […]
