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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
June 1, 2017
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 […]
May 19, 2017
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 […]
