September 10, 2020
On July 6th, the FDA approved its 28th biosimilar, HULIO (adalimumab-fkjp). The approval also represents the sixth biosimilar approved by the FDA for adalimumab (HUMIRA). The first was AMJEVITA (adalimumab-atto), approved in September 2016, and the most recent was ABRILADA (adalimumab-afzb), approved in December of 2019. Like its reference product, HUMIRA (adalimumab), HULIO is approved a […]
August 30, 2020
A sweeping and controversial reform of Canada’s 30-year old regime overseeing patented medicine prices is already creating negative impacts in the life sciences sector and reducing patients’ access to medicines, according to a new report from Innovative Medicines Canada and Life Sciences Ontario. The regulations, drafted by Canada’s Patented Medicine Prices Review Board (PMPRB) were published […]
August 30, 2020
The month of August saw two new biosimilars launch in Canada: The first, Ziextenzo, is a biosimilar pegfilgrastim- a long-acting form of recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF), or filgrastim. It is was approved April 21st of this year by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients […]
August 30, 2020
On August 28th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled “European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution”. The paper explores in detail the findings of ASBM’s survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. Topics examined include […]
August 10, 2020
On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to July 30th.) When the comment period was initially announced, several biologic medicines had been proposed- […]
July 1, 2020
Comment Period on NIOSH Hazardous Drugs List Extended to July 30th The National Institute for Occupational Safety and Health (NIOSH) has extended the comment period regarding its proposed Hazardous Drugs List additions for 2020. The comments on the proposed list are now due July 30th. Several biologic medicines have been proposed- in ASBM’s view inappropriately- […]
June 15, 2020
During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences. EULAR E-Congress (From June 3) ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, […]
May 30, 2020
newsletter | April-May 2020 issue 88 Who We Are The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. […]
May 13, 2020
On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies […]
May 12, 2020
ASBM Whitepaper: Lessons from European Biosimilar Markets On March 25th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled Policy recommendations for a sustainable biosimilars market: lessons from Europe. The paper was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The biosimilar market in Europe is the […]
