ASBM Hosts Naming Roundtable With WHO, FDA, Health Canada

July 13, 2018

On July 12, in Washington, DC the Alliance for Safe Biologic Medicines (ASBM) hosted the second in a series of meetings to discuss the global harmonization of nomenclature for biologic and biosimilar medicines. Representatives from the World Health Organization, the U.S. Food and Drug Administration (FDA), Health Canada, the United States Pharmacopeia (USP), and the American […]

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ASBM Exhibits at DIA 2018 Conference

June 30, 2018

From June 25-27, ASBM exhibited at the 2018 Drug Industry Association Conference (DIA 2018). ASBM was represented at DIA by Chair Madelaine Feldman MD, FACR and Advisory Board Chair Philip Schneider, MS FASHP. In addition to meeting attendees at ASBM’s booth, Drs. Feldman and Schneider attended several panels related to biosimilar policy, and engaged participants […]

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ASBM Presents on Naming at World Biosimilar Congress USA 2018

June 12, 2018

On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers. ASBM Advisory Chair Philip Schneider gave a presentation […]

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FDA Approves 11th Biosimilar

June 6, 2018

On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb). This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), […]

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ASBM Presents at World Health Professions Regulation Conference

May 20, 2018

On May 19th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.   ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.   The findings […]

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ASBM Presents at 66th WHO Naming Meeting

May 18, 2018

On May 1st, ASBM Executive Director, Michael Reilly, Esq. and Advisory Board Chair, Philip Schneider, MS, FASHP; presented before the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the tenth INN Consultation at which ASBM has presented since 2013.  While the discussions in the Open Session at which ASBM presented are […]

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FDA Approves Tenth Biosimilar

May 15, 2018

On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce […]

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ASBM Hosts Forum on International Naming Harmonization

April 12, 2018

On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines.  Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]

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93% of Americans are Now Covered by Biosimilar Substitution Laws

April 1, 2018

Philip J. Schneider, MS FASHP ASBM Advisory Board Chair This week, West Virginia Governor Jim Justice and Wisconsin Governor Scott Walker signed bills updating pharmacy regulations in their respective states. The new laws permit pharmacists to substitute interchangeable biosimilars in place of an originator biologic medicine when they are approved by the FDA. The signing […]

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ASBM Submits Comments to Health Canada on Naming

February 10, 2018

On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored […]

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