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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 […]

ASBM publishes paper on biosimilar naming

November 30, 2012

The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum. The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic […]

ASBM Says Distinct USAN Names for Biosimilars are Needed

November 29, 2012

The Alliance for Safe Biologic Medicines (“ASBM“), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion,” urges FDA in a new paper to adopt unique non-proprietary names […]

ASBM Paper on Biosimilar Naming Published in the Food and Drug Law Institute’s Policy Forum

November 28, 2012

Unique names key factor to ensure patient-safety in biosimilar pathway WASHINGTON – The Food and Drug Law Institute (FDLI) Policy Forum today published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM). “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar […]

ASBM Statement on Automatic Substitution

October 26, 2012

The Patient Protection and Affordable Care Act passed by Congress and signed into law by President Obama in March 2010, contained a provision establishing an abbreviated pathway for the approval of biosimilars (also referred to as followon biologics, or subsequent entry biologics) in the U.S. In February 2012, the U.S. Food and Drug Administration (FDA) […]

Inside Health Policy: Stakeholders Debate Biologic Product Drift’s Impact On Biosimilars

October 25, 2012

One biosimilar developer is pushing FDA to address how changes to innovator biologics over time could affect biosimilar products that reference them, advocating for the agency to use comparability standards as a basis for determining biosimilarity, allow biosimilar determinations based only on one version of an innovator product if drift occurs and investigate ways to […]

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 […]

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 […]

Pharma Times: Physicians concerned at biosimilar “confusion,” study shows

September 18, 2012

86% of physicians responding to a new US survey say they want to be notified before a patient is switched to a different biologic product than the one prescribed, even if there are no known concerns associated with it. And 85% of physicians responding to the poll said that they want to have the authority […]

Bloomberg/BNA: Biologics, Biosimilars Should Have Unique Names to Ensure Safety, Group Says

September 18, 2012

All biologic drugs, including biosimilars, should be required to have unique names to ensure their safety, the Alliance for Safe Biologic Medicines (ASBM) said Sept. 13. ASBM released a survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution. ASBM said these policy issues remain unresolved and will have “a fundamental […]