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 […]
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. […]
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.
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 […]
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of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that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 […]
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 […]
FDA’s Draft Biosimilar Guidance: A Good First Step
February 27, 2012
By Richard Dolinar A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex […]
Alliance to Host Capitol Hill Forum
February 22, 2012
Alliance to Host Capitol Hill Forum The Alliance for Safe Biologic Medicines and Bloomberg Government will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development. Panelists include: Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator) Dr. Richard Dolinar, […]
Alliance member partner, AfPA, video on the benefits of biologics
February 15, 2012
The National Physicians Biologics Working Group today released an educational video featuring a discussion about the benefits of biologic therapies and how they differ from conventional pharmaceuticals. In the four minute video, David Charles, M.D., Chairman of the Alliance for Patient Access, discusses the importance of formulating public policies that ensure access to these biologic […]
