January 6, 2021
According to the editors of the Journal of the Generics and Biosimilar Initiative (GaBI Journal), the most-viewed biosimilars article of 2020 was the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, co-authored by ASBM’s Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The article was published online in February 2020 and in […]
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 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 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 6, 2020
The World Health Organization (WHO) recently released the results of a 20-country survey which identified barriers to biosimilar adoption, the Center for Biosimilars reports. Entitiled “Regulatory challenges with biosimilars: an update from 20 countries”, the survey was a follow-up to one conducted ten years prior. While most of the issues identified in the earlier survey have been resolved, […]
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 […]
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 18, 2020
On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access hosted its fifth annual National Policy & Virtual Summit on Biologics. As part of the Summit, ASBM Chair Madelaine Feldman, MD, FACR, was interviewed by AfPA’s Gavin Clingham about ASBM’s new whitepaper “US Biosimilars Market on Pace with Europe”; published […]
