Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
Medscape Interview with Dr. Margaret Hamburg
Eric Topol, Editor-in-Chief of Medscape, sat down with Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), as part of the Medscape series on the most interesting people in medicine. In the interview “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” Dr. Hamburg addresses biosimilars.
Watch the interview here.