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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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 […]

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ASBM Exhibits at Digestive Disease Week 2017

May 12, 2017

May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups. Mr. Spiegel discussed the importance of […]

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VIDEO: Pharmacists and Biosimilars

May 4, 2017

In this video, ASBM’s Advisory Board Chairman Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy; and Advisory Board Member Ronald Jordan, Dean of the Chapman University School of Pharmacy discuss the role of pharmacists with respect to biosimilars.    

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FDA Approves Fifth Biosimilar

May 2, 2017

On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee. Advisory committees provide FDA with independent opinions and […]

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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 […]

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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 […]

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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 […]

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New research reveals how Australian physician confidence in prescribing biosimilars could be bolstered

February 16, 2017

  A leading authority on international biosimilar medicines policies today released new research that identifies key areas to improve Australian physicians’ confidence in prescribing biosimilar medicines.   The Alliance for Safe Biologic Medicines (ASBM), a non-profit organization, surveyed 160 Australian physicians who prescribe biologics from seven therapeutic specialties with respect to their beliefs and attitudes […]

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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 […]

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ASBM Statement on FDA’s Final Naming Guidance

January 13, 2017

FOR IMMEDIATE RELEASE ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products (Issued January 12, 2017) ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming: We commend the FDA for its continued leadership in emphasizing the importance […]

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