April 19, 2012
The Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA outlining recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway. Read the ASBM Comments.
April 17, 2012
by RICHARD DOLINAR, MD As a treating physician who also serves as the Chairman of the Alliance for Safe Biologic Medicines (ASBM), I have been watching with great interest as the Food and Drug Administration (FDA) begins to unveil the approach it will take to bring “biosimilar” medications to the US. Biosimilars are attempts to […]
April 16, 2012
Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps […]
March 6, 2012
Chairman Dr. Dolinar Speaks at Top Biosimilars Industry Conference Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, presented at the CBI’s 7th Summit on Biosimilars and follow-on Biologics on “Track and Trace – The Need for Pharmacovigilance with Biologics”. […]
February 27, 2012
By Richard Dolinar A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex […]
February 23, 2012
Presented by Dr. Richard Dolinar, MD What is pharmacovigilance Track & Trace systems for biologic medicines Coding, Naming, Labeling Down the Road: Interchangeability and Drug Substitution
February 14, 2012
The Alliance for Safe Biologic Medicines will host its third webinar on biologic and biosimilar medicines on Thursday, February 16, 2012. Click here to register! The webinar will be hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Pharmacovigilance 101: What is it and why is it important? Thursday, February 16, 3:00 PM ET […]
February 9, 2012
Urges FDA to put patient safety first as draft guidance finalized WASHINGTON, Feb. 9, 2012 — In response to the release of the U.S. Food and Drug Administration’s long-awaited draft guidance on the approval of biosimilar medicines in the United States, Dr. Dolinar, Chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following […]
January 4, 2012
By Helena R. Berger Florida Sun Sentinel January 4, 2012 A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and […]
December 21, 2011
By John Horton Huffington Post Seventeen years ago, Ronald Reagan penned what some have called his “Long Goodbye”: a letter to the American people announcing that he had been diagnosed with Alzheimer’s disease. He poignantly thanked readers for allowing him to serve as president. “I only wish there was some way I could spare Nancy […]
