Minnesota Budget Passes Without Biosimilar Provisions 

July 12, 2021

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.   Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, […]

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ASBM Reviews Problems with Pharmacovigilance Programs and Biologics at DIA 2021 Global Annual Meeting

July 7, 2021

From June 27-July 1, 2021, ASBM virtually presented present a poster the DIA Global Annual Meeting 2021 entitled “A Review of Problems with Pharmacovigilance Programs and Biologics”. The poster is authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. Dr. Schneider presented the poster in a video recording available to conference attendees for the duration of the […]

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ASBM Launches Online Biosimilars Course for Pharmacists

June 12, 2021

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 pharmacists nationwide. The first entry in the series is […]

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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 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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