FDA: “Incorrect” to Assume Interchangeables Are More Effective Than Biosimilars

October 10, 2022

As reported in Generics Bulletin October 10th, Dr. Sarah McMullen, India country director for the US Food and Drug Administration underscored that there’s no real distinction in the standards to determine the safety or efficacy for both biosimilars and interchangeable biosimilars, and put forth a “fact check” to dispel the general notion among patients that interchangeables are […]

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American Academy of Ophthalmology Statement on Biosimilar Substitution

October 6, 2022

  AMERICAN ACADEMY OF OPHTHALMOLOGY“‘ POLICY STATEMENT The Use of Biosimilars in Ophthalmic Practice   Background Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated approval pathway for biological products that are demonstrated to be biosimilar to or interchangeable with a Food and Drug Administration (FDA)-approved biological product.1 […]

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ASBM Presents at World Drug Safety Congress

October 6, 2022

On October 4-5, 2022 ASBM Advisory Board Chair Philip Schneider participated in the World Drug Safety Congress Americas 2022, held in Boston, MA. The annual pharmacovigilance (PV) conference bills itself as “the largest commercial gathering of PV professionals in the world. During the two-day conference, Prof. Schneider chaired both the Global PV Track and Advanced Therapies […]

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OSU College of Pharmacy Adds Two New Modules to ASBM CE Course

September 4, 2022

In August, ASBM recorded two new entries in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. These represent part 4 and 6 of the 7-part series covering a wide range of biosimilar policy issues. View the previous three entries here. Module 4: Physician Perspectives on Biosimilars In this module, […]

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June 2022 Newsletter

August 8, 2022

REGISTRATION OPEN: July 20th ASBM/GaBI Webinar on Non-Medical Switching On July 20th, ASBM and the Generics and Biosimilar Initiative (GaBI) will co-host the second in a series of webinars about key biosimilar policy issues. The webinar is entitled “Non-Medical Switching of Biologicals/Biosimilars: Canada, Europe and the US: Overview of Non-Medical Switching Practices of Biologicals/Biosimilars in Different Regions […]

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ASBM & GaBI Host Webinar on Non-Medical Switching

July 5, 2022

On July 20th, 2022 ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a 2-hour webinar entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US” The event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch the webinar here. Academic […]

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ASBM Chair Presents Poster on US Physician Survey at DIA Global Annual Meeting 2022

June 24, 2022

On June 20th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF presented a poster at the DIA Global Annual Meeting 2022 in Chicago, IL. The poster was entitled “U.S. Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” and featured results from ASBM’s 2021 survey of 401 U.S. physicians. Among its key findings: Nearly all physicians surveyed expressed […]

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ASBM & GaBI Webinar “Key Factors for Successful Uptake of Biosimilars in Europe and US”

June 1, 2022

On June 29th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled “Key Factors for Successful Uptake of Biosimilars: Europe and the US: measures taken for improving biosimilar uptake and the potential role of healthcare providers and patients”. The event featured a keynote presentation by former U.S. Deputy Secretary of Health and Human Services […]

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FDA/University of Maryland Biosimilars Workshop Online

May 24, 2022

On April 13th, the U.S. Food and Drug Administration (FDA) and The University of Maryland Center of Excellence in Regulatory Science (M-CERSI) held an educational webinar entitled “Biosimilars: A Decade of Experience and Future Directions-Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology”. In the workshop, leading academic clinicians with specialties in oncology, […]

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ASBM to Present U.S. Physician Survey Data at DIA Global Annual Meeting

May 5, 2022

On June 20th, ASBM Chairman Ralph McKibbin, MD will present a poster entitled “Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” at the 2022 DIA Global Annual Meeting in Chicago, IL. The poster is based on the findings of ASBM’s September 2021 survey of 401 U.S. physicians. While topline findings have been shared privately in meetings […]

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