New Leadership Means New Opportunities for Better Policy

November 15, 2017

By Michael Reilly Executive Director, ASBM Prior to serving as ASBM’s Executive Director, I worked from 2002-2008 at the U.S. Department of Health and Human Services (HHS), including three years as Associate Deputy Secretary under Alex M. Azar, who was nominated recently as HHS Secretary. As a former health regulator, I understand the challenges we face when trying […]

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The EU Biosimilars Experience: Missed Opportunities

June 21, 2017

By Michael S. Reilly, Esq. Executive Director, ASBM If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe […]

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What a Difference a Year Makes!

November 18, 2016

Philip J. Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice.  The 5-hour […]

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One of These is Not Like the Other …

November 7, 2016

Harry L. Gewanter, MD, FAAP, FACR Chairman, ASBM   Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an […]

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Why Meaningful, Memorable Biologic Suffixes Are Like Red Light Cameras

September 21, 2016

By Michael Reilly, Executive Director, ASBM To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz). The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable […]

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A Picture is worth a thousand words…

September 15, 2016

A Picture is worth a thousand words… Why Memorable Names are preferred by Pharmacists by Philip Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair Yesterday, I was in Philadelphia with a group of about 50 pharmacy students and faculty speaking about biosimilars and the role they do play and […]

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CMS Biosimilars Rule: Rulemaking Malpractice

May 26, 2016

  by Kenneth Fisher, MD Nephrologist, ASBM Advisory Board Member Biologic medicines are one of the most powerful tools physicians have to treat patients with serious conditions like cancer, rheumatoid arthritis, hepatitis, and multiple sclerosis. Copies of these therapies, called biosimilars, are becoming available in the U.S., and offer patients new treatment options, potentially at […]

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The Evolution of Good Policy: An Educator’s Perspective

May 20, 2016

  By Philip Schneider, MS, FASHP ASBM Advisory Board Chair Having spent 40 years educating students, legislators, patients, and others about medications and pharmacy practice, I’ve learned that the key to changing minds is usually to get people to see things from a new, different angle. For example, as states grapple with how to handle […]

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70 Stakeholder Groups Call on the FDA, Urging Distinguishable, Meaningful Suffixes for Biosimilars

May 11, 2016

WASHINGTON, DC—In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars. The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random […]

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