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
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 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 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 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.
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
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 […]
