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of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that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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Biologic Drugs: Biosimilars May Be Cheaper, But Are They Safe?

December 14, 2010

Where there’s medicine, there’s money.

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FDA must establish safe approval pathway for biosimilar drugs

December 14, 2010

Biologic drugs are often referred to as ”miracle drugs“ for good reason…

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FDA must establish safe approval pathway for biosimilar drugs

December 14, 2010

Biologic drugs are often referred to as ”miracle drugs“ for good reason…

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Proceed with caution on creating ‘biosimilar’ drugs

November 15, 2010

Americans elected a new Congress on Nov. 2, but the voting booth wasn’t the only place where critical issues were at stake that day.

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Proceed with caution on creating ‘biosimilar’ drugs

November 15, 2010

Americans elected a new Congress on Nov. 2, but the voting booth wasn’t the only place where critical issues were at stake that day.

Read More