FDA Biosimilars Education Bill Signed

May 18, 2021

On April 23rd, President Biden signed into law S. 164, the “Advancing Education on Biosimilars Act of 2021,” which authorizes the Food and Drug Administration (FDA) to educate consumers and health care providers on biologic products, including biosimilars. In March, the US Senate unanimously passed the bill, which directs the FDA to improve education on biosimilars with […]

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Oklahoma Becomes Final State to Permit Biosimilar Substitution 

May 18, 2021

On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution. SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a […]

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ASBM Presents to World Health Organization at 72nd INN Consultation

May 10, 2021

On April 13th, ASBM presented to the World Health Organization’s (WHO’s) 72nd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the sixteenth 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 […]

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ASBM to Chair Multiple Panels at Festival of Biologics USA 2021

March 10, 2021

From March 29-April 1st, ASBM will be participating in the Festival of Biologics USA, part of the World Biosimilar Congress USA 2021. The event is typically held in San Diego, CA but will be held virtually this year due to travel restrictions related to the COVID-19 pandemic.   At the event, ASBM Steering Committee Member Andrew Spiegel […]

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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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