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.
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. […]
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 […]
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 […]
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 […]
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 […]