ASBM Submits Comments on FDA Interchangeability Guidance

May 19, 2017

On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF.   May 22, 2017   Division of Dockets Management (HFA-305)here. Food and Drug Administration Department of Health and Human Services […]

Read More


ASBM Presents at WHO 64th Naming Meeting

April 5, 2017

On April 4rd, in Geneva, Switzerland, ASBM participated in the World Health Organization’s 64rd Stakeholder Consultation on International Nonproprietary Names. ASBM has been a regular participant at the INN Consultations since 2013. ASBM’s Chairman Harry L. Gewanter, Advisory Board Chair Philip Schneider, MS, FASHP and Advisory Board Member Jeff Jones, PhD represented ASBM at this […]

Read More


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support […]

Read More


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support […]

Read More


ASBM’s Schneider testifies in support of NM Substitution Bills

February 21, 2017

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support  and the Senate Corporations and Transportation Committee to support HB 260 and SB […]

Read More


ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill

January 26, 2017

On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day.  Read ASBM’s letter of support for HB 2107 […]

Read More


ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill

January 26, 2017

On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day.  Read ASBM’s letter of support for HB 2107 […]

Read More


ASBM Conducts CE Course for 100 NY Pharmacists

November 14, 2016

On November 13th, ASBM conducted a 5-hour Continuing Education (CE) course for 100 New York pharmacists in Queens, NY. The course, entitled “Biosimilars and Biologics- Regulatory and Practice Issues for Pharmacists” was presented in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy). The course was a follow-up to the 5-hour course ASBM and LIU-Pharmacy presented in March […]

Read More


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 […]

Read More


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 […]

Read More