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 […]
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. […]
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 […]
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 […]
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 largest in the world, representing approximately 60% of […]
In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living. From the letter: We have concerns regarding implementation of […]
On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly. The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring over the coming years, and biosimilars will be entering the marketplace. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.
The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
