Alliance for Safe Biologic Medicines Responds to Supreme Court Decision

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 […]

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ASBM Advisory Board Members Convene on Physician Notification

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.

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ASBM Advisory Board Members Convene on Physician Notification

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.

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Dr. Dolinar Pens Article for BIO Newsletter

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

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ASBM Highlighted in Inside Health Policy Article

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 […]

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ASBM’s Dr. Dolinar quoted in PharmaTimes

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. […]

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ASBM Submits Comments to FDA

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.  

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KevinMD: Involve Doctors in Any Drug Substitution Process Involving Biosimilars

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 […]

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A Safe Pathway to Biosimilars

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 […]

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Biosimilar Products Must Be Uniquely Named

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 […]

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