Geneva — ASBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines […]
Brussels — Today, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in Q3 of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the […]
On February 25, ASBM held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars. The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and Emerging Challenges” focused on the challenges facing world regulators including the U.S. Food and Drug […]
On October 26, Dr. Richard Dolinar served as the keynote luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health in Las Vegas. Dr. Dolinar discussed the science and policy issues surrounding biosimilar provisions of the Patient Protection and Affordable Care Act with state legislators from across the […]
On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations by CBER officials, Diane Maloney, Associate Director for Policy, and Mary Malarkey, director in the […]
On December 13th, ASBM members were invited to take a tour of a biologics manufacturing facility in Rhode Island to learn about the intricacies and complex processes involved with making biologic medicines.
The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” on September 27, 2012 in Phoenix, AZ, to discuss the complex challenges the Food and Drug Administration (FDA) faces as it seeks to establish a regulatory pathway that will lead to the approval […]
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 […]
On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. The two-day event was set up to establish a global network of individual patient […]
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.