WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) presented on March 5, 2013 at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C. Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.
“Creating global standards for biosimilars has to boil down to one thing – patient safety – no matter where in the world the biosimilars are approved,” said Dr. Dolinar. “To safely bring biosimilars to patients, we should build on the science-based approach taken by the European Union (EU) and establish quality standards regarding the approval process, approach to naming, and substitution policies.”
“There is much to be learned from the great progress that has already begun in the EU, Canada and other countries. ASBM is committed to supporting the efforts of the U.S. Food and Drug Administration in their mission to safely bring biosimilars to the U.S., and helping develop and endorse standards that will bring effective biologic and biosimilar treatments to patients across the world.”
View Dr. Dolinar’s full presentation here.
Biologics are used to treat cancer, diabetes, MS, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.