June 6, 2018
On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb). This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), […]
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 […]
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 5, 2018
On January 4th, the Roanoke Times published an op-ed by Stacie Phan, Executive Director of the Biosimilars Forum, discussing the potential cost savings of biosimilars, especially to the Medicare program: “…a recent decision by the Centers for Medicare & Medicaid Services to change a billing policy that jeopardized the long-term stability of the biosimilars market could also help pave the way for […]
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 […]
November 15, 2017
By Michael Reilly Executive Director, ASBM Prior to serving as ASBM’s Executive Director, I worked from 2002-2008 at the U.S. Department of Health and Human Services (HHS), including three years as Associate Deputy Secretary under Alex M. Azar, who was nominated recently as HHS Secretary. As a former health regulator, I understand the challenges we face when trying […]
