PHOENIX – The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and Arizona Bio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” in Phoenix, AZ. The forum provided an opportunity for robust discussion of the complex challenges associated with ensuring the safety of all biologic medicines, as well as the benefits that patients will see from the availability of biosimilars in the U.S.
Members of the patient, physician, pharmacist and research communities provided an educational overview of biologic medicines and the biosimilars that aim to replicate them.
Following a “Biosimilars 101” presentation by ASBM Chairman Dr. Richard Dolinar, Joan Koerber-Walker, president and CEO for AZBio, moderated a panel discussion during which the participants addressed the challenges of ensuring patient-safety as biosimilars are approved in the U.S. Because biosimilars will not be identical to the products they copy, FDA must content with several safety considerations that are generally not an issue for generic drugs. These include what scientific name a biosimilar should be given and how a biosimilar will be deemed “interchangeable” in light of having structural differences from the original product.
Panelists were Philip J. Schneider, Professor and Associate Dean of the University of Arizona College of Pharmacy; Eric Thompson, PhD, Director of Biomarker Research for Paradigm and International Genomics Consortium; Brett Johnson, PhD, International Cancer Advocacy Network and Patricia Lucente, who is a patient advocate with the Colon Cancer Alliance.
“The Alliance for Safe Biologic Medicines has been working to support regulatory efforts to safely bring biosimilars to our country for the past two years by providing the FDA with our recommendations, conducting educational webinars and by recently releasing a survey on physician practices relevant to ensuring safe use of biologics. It is essential that patient-safety is the cornerstone of the biosimilar pathway,” said Dr. Dolinar. “We have held several educational forums to raise awareness on these life-saving, yet extremely complex medicines, and it has been a pleasure to hold such a great event in my hometown with ICAN and AZBio and all of the participants.”
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 On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics.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.