December 17, 2020
On December 17th, the US Food and Drug Administration (FDA) approved Rianbi (rituximab-arrx). Rianbi (rituximab-arrx) is manufactured by Amgen and the third FDA-approved biosimilar to Genentech’s Rituxan (rituximab). It is the third biosimilar FDA has approved in 2020 and the 29th approved in the past 5 years. Read more about the successes FDA’s of the biosimilar program here. […]
December 9, 2020
On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq. Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons […]
December 1, 2020
On November 22nd and 29th, ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider presented to the Saudi Gastroenterology Association. The 45-minute presentation was livestreamed to gatherings of several hundred gastroenterologists in the three largest cities in Saudi Arabia: Riyadh, Jeddah, and Dammam. Entitled “Lessons from European Biosimilar Markets”, the presentation was based on […]
November 18, 2020
On November 15th, ASBM submitted comments on the United Kingdom’s Medicines and Healthcare products Regulatory Agency’s (MHRA’s) guidance intended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK. The new guidance is based on current EMA biosimilar guidance, with additional details about: UK reference products the lack of requirement […]
November 11, 2020
On November 5th and 6th, ASBM exhibited virtually at American College of Rheumatology (ACR) Convergence 2020. The virtual conference took place ran from November 5 – 9, with dedicated exhibit hours on November 5th and 6th. More than 15,000 attendees from 106 countries attended the meeting. ASBM’s virtual booth promoted recent ASBM whitepapers and posters, including a poster presented […]
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 […]
September 15, 2020
Comptant plus de 60 produits approuvés, l’Europe constitue le chef de file incontesté des biosimilaires, et le plus important marché de biosimilaires au monde, avec des taux d’adoption pouvant atteindre 91 % pour les produits plus anciens (avant l’approbation du premier anticorps monoclonal biosimilaire en 2013) et jusqu’à 43 % pour les produits plus récents (approuvés après […]
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 […]
