CMS Reverses Course on Shared Billing Codes for Biosimilars

November 5, 2017

On November 2nd, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for the 2018 Physician Fee Schedule, which governs reimbursement rates for physicians.    In a significant development, beginning in 2018 CMS will update payment for biosimilars. Under the previous rule finalized in 2015 under the Obama Administration, all of the biosimilars sharing one reference […]

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ASBM Presents at 65th WHO Naming Meeting

October 20, 2017

On October 17th, ASBM Chair, Madeline Feldman, M.D., FACR; Advisory Board Chair, Philip Schneider, MS, FASHP; and Executive Director, Michael Reilly, Esq. appeared before the 65th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland.   ASBM has regularly appeared before the INN Consultation since 2013 and continues to advocate for distinguishable […]

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Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey

October 17, 2017

For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~   Ottawa, Ontario (November 22, 2017) – A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]

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ASBM Presents Poster at ESMO 2017

September 15, 2017

On September 10, 2017 ASBM presented a poster at the European Society of Medical Oncology (ESMO) 2017 Congress which presented perspectives of oncologists from 12 countries regarding biosimilar substitution. Responses were drawn from five recent ASBM surveys which gathered perspectives of more than 1,850 biologic prescribers in Australia, Canada, France, Germany, Italy, Spain, the United Kingdom, and the […]

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ASBM Supports WHO Naming Plan in Comments to Australia’s TGA

September 12, 2017

On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s […]

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ASBM Welcomes Madelaine Feldman as Chair

September 7, 2017

ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organization’s incoming chairperson. Dr. Feldman succeeds outgoing chair Harry L. Gewanter, MD, FAAP, FACR, whose 3-year term expired August 31, 2017. Dr. Feldman will be the third chairperson since ASBM was founded in 2010. […]

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FDA Approves Sixth Biosimilar; Second for Humira

August 28, 2017

On August 25th, the US Food and Drug Administration (FDA) approved Cyzelto adalimumab-adbm (Cyltezo, Boehringer Ingelheim) for multiple indications. Cyltezo is a biosimilar of AbbVie’s Humira (adalimumab). This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016. Cyltezo is a tumor necrosis factor (TNF) blocker approved for the treatment of adults […]

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ASBM Presents Poster at Australian Oncologist Conference

August 8, 2017

On August 3rd in Melbourne, Australia, ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented a poster at the 2017 Annual Scientific Meeting of the Medical Oncology Group of Australia (MOGA). Nearly 400 Australian medical oncologists gathered for this meeting, themed Real World Oncology: Translating Discovery in to Practice. View the poster […]

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VIDEO: Innovator Biologics and Biosimilars

July 21, 2017

Please enjoy this video covering the history of biologic medicines, differences between innovator biologics and biosimilars, and current policy considerations –courtesy of ASBM member group the Gastrointestinal Society.

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ASBM Chairman, Members Testify at FDA Oncologic Drugs Advisory Committee Meeting

July 13, 2017

On July 13th, the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) approved the use of two new biosimilar applications. Amgen’s biosimilar application for Genentech/Roche’s Avastin (bevacizumab) was approved by a vote of 17-0 for all indications, which includes metastatic colorectal cancers, non–small cell lung cancer, glioblastoma and cervical cancers. The data package provided […]

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