November 10, 2020
Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK) The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidance intended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK. The new guidance is based on […]
November 9, 2020
This month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR. The paper explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 […]
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 […]
October 30, 2020
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, and has raised concerns among patient and physician organizations worldwide. […]
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 6, 2020
GaBI Publishes ASBM Whitepaper on European Physician Survey 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 […]
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
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 […]
