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.
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 […]
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of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that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 […]
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 […]
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 […]
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will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development.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, […]
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 […]
February 14, 2012
The Alliance for Safe Biologic Medicines will host its third webinar on biologic and biosimilar medicines on Thursday, February 16, 2012. Click here to register! The webinar will be hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Pharmacovigilance 101: What is it and why is it important? Thursday, February 16, 3:00 PM ET […]
February 9, 2012
The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said […]
