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 […]
November 29, 2012
The Food and Drug Law Institute (FDLI) Policy Forum published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM). The white paper is titled, “It’s All About the Name: What is the Imperative of Adopting Unique Names for Biologic and Biosimilar Therapeutics?” and explains that biologic medicines are different […]
November 29, 2012
The Alliance for Safe Biologic Medicines (“ASBM“), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion,” urges FDA in a new paper to adopt unique non-proprietary names […]
November 29, 2012
The Alliance for Safe Biologic Medicines (“ASBM“), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion,” urges FDA in a new paper to adopt unique non-proprietary names […]
November 28, 2012
Unique names key factor to ensure patient-safety in biosimilar pathway WASHINGTON – The Food and Drug Law Institute (FDLI) Policy Forum today published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM). “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar […]
November 15, 2012
In an article titled “Polysorbates, Immunogenicity, and the Totality of the Evidence” author Edward T. Maggio, quotes Dr. Dolinar’s testimony at the FDA pubic hearing, saying: “Unwanted immunogenicity is the preeminent safety challenge associated with all biological therapeutics and can result in unexpected and sometimes severe adverse effects. Complicating matters, side-effects may only appear in […]
