September 10, 2020
Alberta’s Shadow Health Minister, Matt Jeneroux, has used a recent implementation delay for new drug pricing guidelines from the Patented Medicines Pricing Review Board (PMPRB) to collect additional feedback about the proposed changes and will be presenting a comprehensive report to the government in the fall based on his findings. Originally scheduled to take effect on […]
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
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
An article in the summer issue of the Journal of the Generics and BIosimilars Initiative (GaBI Journal) emphasizes the need for improved pharmacovigilance with biologic medicines in the UK. The article, entitled “Poor traceability of biologicals in UK ADR reporting indicates the need for improvements to ensure patient safety” covers the UK BIO-TRAC study, which conducted […]
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
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- […]
