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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ASBM Exhibits at June Oncology, Pharmacy Conferences

June 15, 2017

On June 3-5th, ASBM exhibited at the American Society of Clinical Oncologists (ASCO) Annual Meeting in Chicago, IL. There ASBM Chairman Harry L. Gewanter, MD spoke with many physicians, patient advocates and manufacturers about ASBM’s worldwide advocacy on behalf of patients. ASBM shared a booth with Steering Committee member Global Colon Cancer Association, represented by […]

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ASBM Sends Letter to 20 Health Regulators Worldwide Urging Support for BQ

June 12, 2017

On June 6th, ASBM sent a letter to national health regulatory authorities in 20 countries. The letter explains the benefits of distinct names for biologic medicines and ask regulators in different countries to urge the World Health Organization (WHO) to make its Biological Qualifier (BQ) system available to countries who wish to extend its benefits to their […]

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ASBM Presents With CT State Medical Society

June 1, 2017

On May 30th, in partnership with the Connecticut State Medical Society, ASBM presented a 2-hour Continuing Medical Education (CME) course entitled “Biosimilars: New Choices, New Challenges”. The event began with remarks by CSMS President Jeff Gordon, MD, who is Medical Director of Hematology-Oncology Services at Day-Kimball Hospital in Putnam, CT. Dr. Gordon emphasized the great excitement […]

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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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