September 17, 2012
On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability. DIA Presentation on Biosimilar Naming DIA Presentation on Interchangeability During the conference, ASBM released a new survey examining […]
September 7, 2012
ASBM Executive Director Michael Reilly was quoted in the FDA Week story Stakeholders Draw Biosimilar Naming Insight From Biologic Approval. Read the article.
July 23, 2012
Good piece on biosimilars in Forbes by Jon Entine, Senior Fellow at the Center for Health & Risk Communication at George Mason University. Read FDA Balances Costs, Patient Safety in the Biologics and Personalized Medicine
June 28, 2012
WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement in response to the Supreme Court ruling on the Affordable Care Act and its impact on the Food and Drug Administration’s (FDA) creation of a biosimilar pathway. “As biosimilar medicines are introduced into the U.S. in the […]
June 25, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety.
June 18, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety. Read the summary.
June 13, 2012
Physician’s Panel Says Patient Safety Undermined without Unique Names WASHINGTON – In response to a recent letter by the National Coalition on Health Care on the issue of biosimilar naming, the Alliance for Safe Biologic Medicines (ASBM) and members of its National Advisory Board urge the U.S. Food and Drug Administration (FDA) to implement distinguishable […]
May 17, 2012
Dr. Dolinar wrote an article for BIO’s May Newsletter on the FDA hearing and the importance of patient safety when creating a biosimilar pathway. Read Biosimilars Ahead, Proceed with Caution
May 16, 2012
Prepared Remarks Identify Clinical Trials, Global Supply Chain, Unique Naming, Clear Packaging Information, and Interchangeability as Areas for Careful Consideration WASHINGTON — Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on […]
May 16, 2012
ASBM chairman Dr. Richard Dolinar was quoted in a PharmaTimes article covering the May 11 FDA hearing on biosimilars. From US FDA urged over biosimilars: Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, outlined five areas of concern that he said the FDA should resolve before they allow biosimilars onto the US market. […]
