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 European countries. Topics examined include […]

Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution

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 […]

ASBM Exhibits at Three Virtual Conferences in June

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, […]

ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth 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 […]

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 largest in the world, representing approximately 60% of […]

ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific […]

ASBM Presents Fourth 5-Hour CE Course to NY Pharmacists

On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?” to a class consisting of more than 75 New York area pharmacists. The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has […]

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Study: Biosimilar Infliximab Uptake Slow, But Tracks With Europe

Study: Biosimilar Infliximab Uptake Slow, But Tracks With Europe

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 […]

FDA Approves 28th Biosimilar, Sixth for Adalimumab

FDA Approves 28th Biosimilar, Sixth for Adalimumab

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 […]

GaBI Journal: UK Study Shows Need for Improved Identification of Biologics

GaBI Journal: UK Study Shows Need for Improved Identification of Biologics

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 […]

Report: Canada’s Pharmaceutical Pricing Reforms Creating Negative Impacts for Patients

Report: Canada’s Pharmaceutical Pricing Reforms Creating Negative Impacts for Patients

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 […]

Two New Biosimilars Launch in Canada

Two New Biosimilars Launch in Canada

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 […]

Biosimilars 101

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.

Member Partners

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.

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