ASBM Shares Australian Data at BMJD Conference

At the 5th World Congress on Controversies, Debates & Consensus in Bone, Muscle & Joint Diseases (BMJD), ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, recently presented, “Real World Considerations for the Use of Biosimilars in Rheumatology: What do Australian Physicians Think?” The conference took place on the Gold Coast […]

FDA Approves Sixth Biosimilar; Second for Humira

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

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

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

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 […]

ASBM Presents Poster at DIA Annual Meeting

On June 20th, ASBM Chairman Harry L. Gewanter, MD presented a poster based on ASBM’s survey of Australian biologic prescribers, at the DIA 2017 Annual Meeting in Chicago, IL. ASBM exhibited at DIA from June 19th-21st. The survey included 76% of prescribers believed the Therapeutic Goods Administration (TGA) should assign distinct names to all biologics, including […]

ASBM Exhibits at BIO International Conference 2017

On June 18th – 22nd, ASBM exhibited at the Biotechnology Innovation Organization (BIO) International Conference in San Diego, CA. ASBM was represented in the Australian Pavilion by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Alliance. Dean Schneider and Mr. Spiegel distributed summaries of survey […]

The EU Biosimilars Experience: Missed Opportunities

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 […]

ASBM Exhibits at June Oncology, Pharmacy Conferences

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 Presents Poster at ESMO 2017

ASBM Presents Poster at ESMO 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 […]

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

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

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

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. […]

FDA Approves Sixth Biosimilar; Second for Humira

FDA Approves Sixth Biosimilar; Second for Humira

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

ASBM Presents Poster at Australian Oncologist Conference

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 […]

VIDEO: Innovator Biologics and Biosimilars

VIDEO: Innovator Biologics and Biosimilars

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.

Biosimilars 101

Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring over the coming years, and biosimilars will be entering the marketplace. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.

Member Partners

The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

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