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of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that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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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 […]

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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will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development.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, […]

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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 […]

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Alliance to host Webinar: Pharmacovigilance 101: What is it and why is it important?

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 […]

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FDA issues draft guidance on biosimilar product development

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 […]

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Winning Against Cancer with Safe and Effective Treatments

January 24, 2012

By Andrew Spiegel, Chief Executive Officer of the Colon Cancer Alliance (CCA) MedCity News The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990. These promising reductions in the […]

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Concerns linger about biotech drugs

January 4, 2012

By Helena R. Berger Florida Sun Sentinel January 4, 2012 A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and […]

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