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, […]
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 […]
On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in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 […]
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 […]
On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers. Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in […]
Health Minister Tyler Shandro Announces Policy that Eliminates Physician and Patient Choice of Biologic Medicine for Half of Albertans EDMONTON- the Government of Alberta announced that it will begin forcibly switching 26,000 patients from their physician-chosen biologic medicines to government-chosen biosimilars beginning July 1st, 2020. These patients include 22,000 Albertans with diabetes, 2,000 with Crohn’s […]
The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved […]
September 30, 2019 – Barcelona, Spain – The Alliance for Safe Biologic Medicines (ASBM) this week shared preliminary findings from a survey of 575 biologic prescribers in six Western European countries, covering several key policy issues including biosimilar substitution practices, adverse event reporting, and government tendering criteria. Since 2010, the group has routinely surveyed physicians […]
On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. While the discussions in the Open Session […]
Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative VANCOUVER, BC – Wednesday, September 18, 2019. On September 5, 2019, the BC government announced phase two of its Biosimilars Initiative, informing patients prescribed the originator biologic drug, Remicade® (infliximab), to treat inflammatory bowel disease (Crohn’s disease and ulcerative colitis) that this medication […]
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, […]
On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies […]
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 […]
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 […]
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 […]
On March 9th and 10th, two major meetings were held in the nation’s capitol to discuss the barriers to the success of biosimilars in the U.S. marketplace. The first meeting was a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters. The second was a half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum […]
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.
