Media Room – Page 8 – Safe Biologics

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 […]

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 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 Member Releases Position Statement on Substitution

November 7, 2012

The American Academy of Dermatology released a position statement on automatic substitution that calls for several thresholds to all be met before a biosimilar can be substituted. Read the statement here.

BIO Principles on Patient Safety in the Substitution of Biologic Products

October 29, 2012

In August, BIO released Principles on Substitution for Biologic Products. Read the Principles here.

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 […]

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 […]

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 […]