December 21, 2012
On December 6th, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour which was arranged to help attendees better understand the complexities of manufacturing biologics.
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 10, 2012
DENVER – The Alliance for Safe Biologic Medicines (ASBM), Colorado BioScience and Biotechnology Industry Organization (BIO) hosted a Biosimilars Education Forum in Longmont, CO, on December 6th following a tour of a facility that manufactures biologic medicines. The forum brought together policymakers, patient advocates, physicians, pharmacists and other stakeholders who discussed the importance of patient […]
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 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 […]
November 7, 2012
The American Academy of Dermatology released a position statement on automatic substitution that calls for several thresholds to all be met before a biosimilar can be substituted. Read the statement here.
October 29, 2012
In August, BIO released Principles on Substitution for Biologic Products. Read the Principles here.
October 25, 2012
BIO developed the bellow set of Biosimilar Principles to serve as recommendations for Congress for creating a biosimilar pathway: As Congress explores the creation of any regulatory pathway for follow-on biologics, it is essential that Congress recognize and adopt the following key principles: Ensure Patient Safety. Patients should not have to accept greater risks or […]
