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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Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards

February 8, 2018

For Immediate Release Naming Tool for Biologic Medicines Released;  Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018)   The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]

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Alex Azar Sworn in as HHS Secretary 

February 2, 2018

On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance.   Mr. Azar previously spent four years as the Department’s […]

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Biosimilar Innovation Plan Part of FDA’s 2018 Strategic Roadmap

January 12, 2018

On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines.   “We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments […]

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