ASBM’s Andrew Spiegel Interviewed on Susan G. Komen Podcast

January 29, 2021

On January 28, the Susan G. Komen Foundation released an episode of their podcast “Real Pink” entitled  “The Evolution of Biosimilars as a Cancer Treatment” featuring Andrew Spiegel. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a founding member of ASBM.  In the podcast, Spiegel explains how biologic medicines have extended the life expectancy […]

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ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability

January 19, 2021

On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars. These include how an applicant may seek FDA review for […]

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ASBM Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020

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 […]

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FDA Approves 29th Biosimilar, Third for Rituximab

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. […]

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ASBM Presents to Rheumatologists in Saudi Arabia, Kuwait, Iraq

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 […]

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WHO Survey: Lack of International Naming System is Barrier to Biosimilar Adoption

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, […]

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ASBM Presents to Saudi Gastroenterology Association

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 […]

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ASBM Submits Comments on MHRA (UK) Guidance on the Licensing of Biosimilar Products​

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 […]

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US Biosimilar Market on Pace with Europe, says ASBM Chair Madelaine Feldman

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 […]

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ASBM Exhibits at ACR Convergence 2020

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 […]

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