March 1, 2013
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following: “The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway […]
February 27, 2013
The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward. Omontys was recalled following some fatal, severe allergic (anaphylactic) reactions that occurred within 30 minutes of receiving the […]
February 15, 2013
A letter to the editor on the Virginia Biosimilars bill by ASBM Advisory Board member, Dr. Harry Gewanter, ran in the Lynchburg News & Advance. Healing or dollars? As one of the few pediatric rheumatologists in Virginia, I am extremely disappointed by the misinformation presented in The News & Advance’s Feb. 2 article, “Newman’s Senate […]
January 24, 2013
Advisory Board member Dr. Harry Gewanter penned an Op-Ed for the Richmond Times-Dispatch on legislation around biosimilar substitution. Read “Legislation would protect patients taking complex meds.”
January 9, 2013
Inside Health Policy’s “Stakeholders Gear Up For Biosimilar Substitution Battle In 2013” article includes mentions of ASBM and quotes Dr. Dolinar: “Still, groups like the Alliance for Safe Biologic Medicines, which has a broad membership of patient groups and innovator biologic companies, are pressing for a unique naming scheme, saying it is pertinent for ensuring […]
January 9, 2013
Inside Health Policy’s “Stakeholders Gear Up For Biosimilar Substitution Battle In 2013” article includes mentions of ASBM and quotes Dr. Dolinar: “Still, groups like the Alliance for Safe Biologic Medicines, which has a broad membership of patient groups and innovator biologic companies, are pressing for a unique naming scheme, saying it is pertinent for ensuring […]
December 19, 2012
The Alliance for Patient Access National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” The paper examines barriers to therapeutic access resulting from current healthcare benefits design. This is a second in a series of papers designed as an educational resource to inform the public and […]
December 19, 2012
The Alliance for Patient Access National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” The paper examines barriers to therapeutic access resulting from current healthcare benefits design. This is a second in a series of papers designed as an educational resource to inform the public and […]
November 30, 2012
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum. The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic […]
November 30, 2012
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum. The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic […]
