ASBM Authors Second Letter to WHO on Naming

ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO. The second letter is a result of ASBM’s keen interst in the 56th Consultaion on International Nonproprietary Names (INN) for Pharmaceutical Substances, which was held in May, as well as the positive feedback ASBM received from Dr. Raffaella Balocco, INN Program Manager.

Read letter here.

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April 2024 Newsletter

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the […]

March 2024 Newsletter

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. In response, ASBM Executive Director Michael Reilly published a blog post sharing his concerns with the Administration’s proposal to permit widespread automatic (pharmacy-level) substitution of all biosimilars in place of their reference products; without physician approval […]

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars

In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many […]