January 24, 2013
Advisory Board member Dr. Harry Gewanter penned an Op-Ed for the Richmond Times-Dispatch on legislation around biosimilar substitution. Read “Legislation would protect patients taking complex meds.”
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 […]
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) […]
October 25, 2012
BIO developed the bellow set of Biosimilar Principles to serve as recommendations for Congress for creating a biosimilar pathway: As Congress explores the creation of any regulatory pathway for follow-on biologics, it is essential that Congress recognize and adopt the following key principles: Ensure Patient Safety. Patients should not have to accept greater risks or […]
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 […]
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 […]
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 […]
September 17, 2012
On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability. DIA Presentation on Biosimilar Naming DIA Presentation on Interchangeability During the conference, ASBM released a new survey examining […]
September 7, 2012
ASBM Executive Director Michael Reilly was quoted in the FDA Week story Stakeholders Draw Biosimilar Naming Insight From Biologic Approval. Read the article.
June 28, 2012
WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement in response to the Supreme Court ruling on the Affordable Care Act and its impact on the Food and Drug Administration’s (FDA) creation of a biosimilar pathway. “As biosimilar medicines are introduced into the U.S. in the […]
