Safe Biologics

DENVER – The Alliance for Safe Biologic Medicines (ASBM), Colorado BioScience and Biotechnology Industry Organization (BIO) hosted a Biosimilars Education Forum in Longmont, CO, on December 6^th 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 Chairmain, Dr. Richard Dolinar participated in a panel discussion with Andrew Spiegel, CEO of the Colon Cancer Alliance, Philip Schneider, Associate Dean of the College of Pharmacy Administration at the University of Arizona and Fritz Bittenbender, Vice President of Alliance Development and State Government Affairs at BIO.

The 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.

“As a practicing physician, I am often reminded of the differences biologics can make in the lives of my patients, but today was an eye-opening experience as I witnessed firsthand the immense detail and the stringent standards that are required to ensure that biologics are safe and effective,” said Dr. Dolinar. “ASBM has been very supportive of the FDA’s efforts and we believe that by holding forums across the country and engaging physicians, pharmacists, patients and policymakers we will be better able to provide the FDA with solutions to some of the complex patient-safety challenges biosimilars present for manufacturers and regulators alike, but also to remind us all of the promise they will offer to patients in the U.S. once available.”

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 On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics.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.

DENVER – The Alliance for Safe Biologic Medicines (ASBM), Colorado BioScience and Biotechnology Industry Organization (BIO) hosted a Biosimilars Education Forum in Longmont, CO, on December 6^th 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 Chairmain, Dr. Richard Dolinar participated in a panel discussion with Andrew Spiegel, CEO of the Colon Cancer Alliance, Philip Schneider, Associate Dean of the College of Pharmacy Administration at the University of Arizona and Fritz Bittenbender, Vice President of Alliance Development and State Government Affairs at BIO.

The 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.

“As a practicing physician, I am often reminded of the differences biologics can make in the lives of my patients, but today was an eye-opening experience as I witnessed firsthand the immense detail and the stringent standards that are required to ensure that biologics are safe and effective,” said Dr. Dolinar. “ASBM has been very supportive of the FDA’s efforts and we believe that by holding forums across the country and engaging physicians, pharmacists, patients and policymakers we will be better able to provide the FDA with solutions to some of the complex patient-safety challenges biosimilars present for manufacturers and regulators alike, but also to remind us all of the promise they will offer to patients in the U.S. once available.”

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.