The Alliance for Safe Biologic Medicines (ASBM) will host a series of roundtables beginning in September to seek input from the patient, physician and pharmacist communities on the issue of physician notification for biosimilars. The roundtables seek to build on the May 24th ASBM Advisory Board physician notification working group meeting led by Chairman Richard […]
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
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.
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 […]
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.
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.
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
After testifying before the FDA on May 11, Inside Health Policy quoted ASBM chairman Dr. Dolinar. Biologics makers peg biosimilars areas they want clarified: Alliance for Safe Biologics chairman Richard Dolinar said, “Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes. For this reason no two biologics […]
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. […]
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.