May 2021 Newsletter

June 6, 2021

ASBM Launches Online Biosimilars Course for Pharmacists   ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to […]

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Quebec Announces Forced Biosimilar Substitution Policy

May 20, 2021

On May 18th, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars. British Columbia and Alberta have already implemented similar policies, and in April, New Brunswick announced it will follow them.   Starting April 12, 2022, Quebec will cover, “with exceptions,” only the biosimilar version of drugs. “Despite the inclusion of several […]

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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 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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The State of Forced Switching in Canada in 2022

March 10, 2021

Forced Switching: Patient and Physician Concerns As of July 2022, four Canadian provinces, British Columbia, Alberta, New Brunswick, and Quebec have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community. Read about the biosimilar substitution policies of each Province and Territory here. In […]

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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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December 2020

January 6, 2021

ASBM Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020 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. […]

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