ASBM in Brazil

October 9, 2014

ASBM has traveled to cities around the world to participate in regulatory discussions on how to best achieve global safety standards for biosimilars. In August 2014, ASBM representatives took part in several meetings in Rio de Janeiro, Brazil for two different conferences. ASBM Chairman Dr. Harry Gewanter was a guest speaker at the August 13 […]

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BioPharma Article Highlights Important Role of CROs in Biosimilar Development

October 1, 2014

A September 17 BioPharma article pointed out that almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO). Read “Fastest Way to Biosimilar Approval? As the CRO flies” here.

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BioPharma Article Highlights Important Role of CROs in Biosimilar Development

October 1, 2014

A September 17 BioPharma article pointed out that almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO). Read “Fastest Way to Biosimilar Approval? As the CRO flies” here.

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ASBM and Patient Advocates Write FDA on Naming

August 14, 2014

The Alliance for Safe Biologic Medicines (ASBM), along with dozens of patient organizations, write Commissioner Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming as a priority for the well-being of patients. Read full letter here.

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ASBM and Patient Advocates Write FDA on Naming

August 14, 2014

The Alliance for Safe Biologic Medicines (ASBM), along with dozens of patient organizations, write Commissioner Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming as a priority for the well-being of patients. Read full letter here.

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ASBM Names Harry L. Gewanter, MD as Incoming Chairman; Dean Philip Schneider as International Advisory Board Chair

August 7, 2014

ARLINGTON, VA – Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM) today announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy […]

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ASBM Letter to Idaho Board of Pharmacy

August 6, 2014

The Idaho Board of Pharmacy held a hearing on August 5th and 6th regarding proposed regulations for the treatment of biosimilars in their state.  View ASBM letter here.

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ASBM Letter to Idaho Board of Pharmacy

August 6, 2014

The Idaho Board of Pharmacy held a hearing on August 5th and 6th regarding proposed regulations for the treatment of biosimilars in their state.  View ASBM letter here.

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Senate HELP Committee authors letter to HHS Secretary on biosimilars issues

August 1, 2014

View letter here.

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Senate HELP Committee authors letter to HHS Secretary on biosimilars issues

August 1, 2014

View letter here.

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