On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]
For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]
On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored […]
On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World […]
On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines. “We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments […]
On January 4th, the Roanoke Times published an op-ed by Stacie Phan, Executive Director of the Biosimilars Forum, discussing the potential cost savings of biosimilars, especially to the Medicare program: “…a recent decision by the Centers for Medicare & Medicaid Services to change a billing policy that jeopardized the long-term stability of the biosimilars market could also help pave the way for […]
For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~ Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]
On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]
Philip J. Schneider, MS FASHP ASBM Advisory Board Chair This week, West Virginia Governor Jim Justice and Wisconsin Governor Scott Walker signed bills updating pharmacy regulations in their respective states. The new laws permit pharmacists to substitute interchangeable biosimilars in place of an originator biologic medicine when they are approved by the FDA. The signing […]
On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored […]
For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]
On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance. Mr. Azar previously spent four years as the Department’s […]
On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines. “We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments […]
Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring over the coming years, and biosimilars will be entering the marketplace. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.
The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
