Ray Patnaude – Page 16 – Safe Biologics

FDA Launches Biosimilar Education Site for Prescribers

November 5, 2017

On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted. Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, […]

New York Becomes 36th State to Pass Biosimilar Substitution Law

November 5, 2017

On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years. New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) […]

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 […]

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 […]

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 […]

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 organizations 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. […]

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 […]

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 […]

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 […]

ASBM Chairman Presents at Latin American Biosimilars Forum

July 3, 2017

On June 28th, ASBM Chairman Harry L. Gewanter, MD presented to an audience of 150 at the 8th Latin American Biosimilars Forum in Brasilia, Brazil. In his presentation, entitled “Increasing Physician Confidence in Biosimilars”, Dr. Gewanter discussed barriers to widespread acceptance of biosimilars among physicians. Dr. Gewanter cited the example of Australia, where biosimilar uptake remains […]