November 5, 2020
ASBM Launches New Microsite on Forced Switching in Canada On October 28th, ASBM launched a new microsite focused on the issue of forced biosimilar substitution in Canada- the forcing of patients off their physician-prescribed biologics and onto preferred government-chosen products. www.NoForcedSwitching.ca This controversial practice is rare among the advanced countries of the world, […]
October 30, 2020
On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. Due to coronavirus-related travel restrictions in […]
September 15, 2020
Comptant plus de 60 produits approuvés, l’Europe constitue le chef de file incontesté des biosimilaires, et le plus important marché de biosimilaires au monde, avec des taux d’adoption pouvant atteindre 91 % pour les produits plus anciens (avant l’approbation du premier anticorps monoclonal biosimilaire en 2013) et jusqu’à 43 % pour les produits plus récents (approuvés après […]
September 10, 2020
The uptake of infliximab biosimilars in the United States is slow but tracks closely to the experience in Europe, according to a new study. After 2 years, infliximab biosimilars assumed a large share of the Europe market. While biosimilar filgrastim has gained large market share in the U.S., uptake of biosimilar infliximab has lagged that of […]
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- […]
