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 […]

Read More

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 […]

Read More

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.

Read More

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 […]

Read More

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 […]

Read More

ASBM Exhibits at BIO International Conference 2017

June 25, 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 […]

Read More

ASBM Presents Poster at DIA Annual Meeting

June 22, 2017

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 […]

Read More

The EU Biosimilars Experience: Missed Opportunities

June 21, 2017

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 […]

Read More

ASBM Exhibits at June Oncology, Pharmacy Conferences

June 15, 2017

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 […]

Read More

ASBM Sends Letter to 20 Health Regulators Worldwide Urging Support for BQ

June 12, 2017

On June 6th, ASBM sent a letter to national health regulatory authorities in 20 countries. The letter explains the benefits of distinct names for biologic medicines and ask regulators in different countries to urge the World Health Organization (WHO) to make its Biological Qualifier (BQ) system available to countries who wish to extend its benefits to their […]

Read More