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 safety as biosimilars are introduced in the United States.
ASBM Chairman, Dr. Richard Dolinar, participated in a panel discussion with Andrew Spiegel, CEO of the Colon Cancer Alliance, Ronald Jordan, Dean of the University of Rhode Island, College of Pharmacy, Bruce Babbitt with PAREXEL Consulting and Doug Kraus who is a patient advocate.
The Rhode Island manufacturing tour and forum were part of an ongoing ASBM education campaign intended to highlight the complex nature of biologics, the precise methods and processes required to manufacture them and the challenges present in the attempt to replicate them. ASBM participated in a biosimilars education forum in Colorado on December 6th and also hosted a forum in Phoenix, AZ in September.
“Physicians and pharmacists share the same goal of providing safe and effective care for their patients, especially so when it comes to new biologic drugs and the biosimilars that aim to replicate them,” said Dr. Dolinar. “We are grateful to be hosted by the College of Pharmacy to discuss some of the safety challenges biosimilars will present for both physicians and pharmacists and work together to determine solutions that will be best for patients.”
Biologics are used to treat cancer, 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 On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics.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.
The U.S. Food and Drug Administration (FDA) is currently developing a regulatory pathway that will ensure biosimilars are safe for patients as they are introduced in the U.S.
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, innovative medical biotechnology companies, 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.