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
On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. The two-day event was set up to establish a global network of individual patient […]
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.
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 […]
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 18, 2012
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.
April 11, 2012
By Dr. Richard Dolinar Chairman of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused […]
March 2, 2012
Dr. Richard Dolinar, a Glendale, Ariz.-based physician who is ASBM’s chairman, noted that chemical medicines are small molecules that treat the symptoms of illness or disease, but that some biologics, which he described as “huge, engineered structures,” can get to the pathways of illnesses like arthritis or cancer. “A biologic product is not a matter […]
