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) met to consider approval of two biosimilar applications. In the morning session, the ODAC considered Amgen’s biosimilar application for Genentech/Roche’s Avastin (bevacizumab); in the afternoon session, the ODAC considered Mylan GmbH’s application for Genentech’s Herceptin (trastuzumab).  ASBM Chairman Harry L. Gewanter, MD testified at both sessions. […]

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 […]

ASBM Presents With CT State Medical Society

On May 30th, in partnership with the Connecticut State Medical Society, ASBM presented a 2-hour Continuing Medical Education (CME) course entitled “Biosimilars: New Choices, New Challenges”. The event began with remarks by CSMS President Jeff Gordon, MD, who is Medical Director of Hematology-Oncology Services at Day-Kimball Hospital in Putnam, CT. Dr. Gordon emphasized the great excitement […]

ASBM Submits Comments on FDA Interchangeability Guidance

On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF.   May 22, 2017   Division of Dockets Management (HFA-305)here. Food and Drug Administration Department of Health and Human Services […]

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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.

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

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) met to consider approval of two biosimilar applications. In the morning session, the ODAC considered Amgen’s biosimilar application for Genentech/Roche’s Avastin (bevacizumab); in the afternoon session, the ODAC considered Mylan GmbH’s application for Genentech’s Herceptin (trastuzumab).  ASBM Chairman Harry L. Gewanter, MD testified at both sessions. […]

ASBM Chairman Presents at Latin American Biosimilars Forum

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 Exhibits at BIO International Conference 2017

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 […]

ASBM Presents Poster at DIA Annual Meeting

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 […]

The EU Biosimilars Experience: Missed Opportunities

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 […]

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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