EuropaBio joins the Alliance for Safe Biologic Medicines

June 27, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership. EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio […]

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Quality, Manufacturing Transparency Key to Avoiding Biologic Drug Shortages: Dolinar Addresses 49th Annual DIA Conference

June 25, 2013

BOSTON, Mass. — Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

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ASBM Chairman: Patient Safety Key to Creating Global Biosimilar Standards

March 7, 2013

WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) presented on March 5, 2013 at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C. Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines” stressed the need for a global regulatory environment for biosimilars that places patient safety […]

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Alliance for Safe Biologic Medicines Concerned Sequestration Cuts Could Delay Biosimilars Pathway

March 1, 2013

WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following: “The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway […]

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Alliance for Safe Biologic Medicines Hosts Biosimilar Forum at University of Rhode Island, College of Pharmacy

December 21, 2012

PROVIDENCE, RI – The Alliance for Safe Biologic Medicines (ASBM) hosted a Biosimilars Education Forum at the University of Rhode Island, College of Pharmacy in Kingston, RI, following a tour of a facility that manufactures biologic medicines. The forum brought together policymakers, patient advocates, physicians, pharmacists and other stakeholders who discussed the importance of patient […]

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Alliance for Safe Biologic Medicines, Colorado BioScience and the Biotechnology Industry Organization Host Biosimiars Forum in Colorado

December 10, 2012

DENVER – The Alliance for Safe Biologic Medicines (ASBM), Colorado BioScience and Biotechnology Industry Organization (BIO) hosted a Biosimilars Education Forum in Longmont, CO, on December 6th following a tour of a facility that manufactures biologic medicines. The forum brought together policymakers, patient advocates, physicians, pharmacists and other stakeholders who discussed the importance of patient […]

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Alliance for Safe Biologic Medicines Responds to Updated EMA Q&A on Biosimilars

October 2, 2012

WASHINGTON – On September 27, 2012 the European Medicines Agency (EMA) released a revised version of their 2008 Question and Answer (Q&A) document differentiating the regulatory standards for biosimilar medicines from the standards used to support generic chemical medicines. ASBM Chairman Richard Dolinar, MD, released the following statement in recognition of the importance of that […]

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ASBM, ICAN and AZBio Discuss Patient Safety during Phoenix Forum

October 1, 2012

PHOENIX – The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and Arizona Bio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” in Phoenix, AZ. The forum provided an opportunity for robust discussion of the complex challenges associated with ensuring the safety of all biologic medicines, as well as the benefits that […]

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ASBM Survey Reveals Key Safety Concern Associated with Biosimilar Naming; Urges Distinct Naming Requirement

September 17, 2012

WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today announced the results of a new survey on physician opinions relating to biologics and biosimilars. ASBM Chairman, Dr. Richard O. Dolinar, presented key findings during the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C., where he urged the FDA to make patient-safety the […]

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ASBM Advisory Board Members Urge FDA to Adopt Unique Names for Biosimilars

June 13, 2012

Physician’s Panel Says Patient Safety Undermined without Unique Names WASHINGTON – In response to a recent letter by the National Coalition on Health Care on the issue of biosimilar naming, the Alliance for Safe Biologic Medicines (ASBM) and members of its National Advisory Board urge the U.S. Food and Drug Administration (FDA) to implement distinguishable […]

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