July 10, 2012
On July 9, President Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act, that reauthorizes FDA user fees and that will establish new user-fee programs for biosimilar drugs. Read more.
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 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 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 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 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. […]
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. […]
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 […]
