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 […]
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 26, 2012
The Patient Protection and Affordable Care Act passed by Congress and signed into law by President Obama in March 2010, contained a provision establishing an abbreviated pathway for the approval of biosimilars (also referred to as followon biologics, or subsequent entry biologics) in the U.S. In February 2012, the U.S. Food and Drug Administration (FDA) […]
October 25, 2012
One biosimilar developer is pushing FDA to address how changes to innovator biologics over time could affect biosimilar products that reference them, advocating for the agency to use comparability standards as a basis for determining biosimilarity, allow biosimilar determinations based only on one version of an innovator product if drift occurs and investigate ways to […]
October 25, 2012
One biosimilar developer is pushing FDA to address how changes to innovator biologics over time could affect biosimilar products that reference them, advocating for the agency to use comparability standards as a basis for determining biosimilarity, allow biosimilar determinations based only on one version of an innovator product if drift occurs and investigate ways to […]
