December 21, 2012
On December 6th, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour which was arranged to help attendees better understand the complexities of manufacturing biologics.
December 21, 2012
On December 6th, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour which was arranged to help attendees better understand the complexities of manufacturing biologics.
December 19, 2012
The Alliance for Patient Access National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” The paper examines barriers to therapeutic access resulting from current healthcare benefits design. This is a second in a series of papers designed as an educational resource to inform the public and policymakers about the benefits of biologics, what makes them unique and distinct from conventional pharmaceuticals, and why these distinctions matter.
To learn more about the National Physicians Biologics Working Group please visit www.Biologicsdoc.org.
Read the paper here.
December 19, 2012
The Alliance for Patient Access National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” The paper examines barriers to therapeutic access resulting from current healthcare benefits design. This is a second in a series of papers designed as an educational resource to inform the public and policymakers about the benefits of biologics, what makes them unique and distinct from conventional pharmaceuticals, and why these distinctions matter.
To learn more about the National Physicians Biologics Working Group please visit www.Biologicsdoc.org.
Read the paper here.
December 10, 2012
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 6th 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.
December 10, 2012
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 6th 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.
November 30, 2012
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.
The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’ explains the ASBM’s position that in order to ensure patient safety as biosimilars are approved in the US, they must be given distinct, non-proprietary names. The paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway.
Read full article at Generics and Biosimilars Initiative (GaBI)
November 30, 2012
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.
The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’ explains the ASBM’s position that in order to ensure patient safety as biosimilars are approved in the US, they must be given distinct, non-proprietary names. The paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway.
Read full article at Generics and Biosimilars Initiative (GaBI)
November 29, 2012
The Food and Drug Law Institute (FDLI) Policy Forum published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM).
The white paper is titled, “It’s All About the Name: What is the Imperative of Adopting Unique Names for Biologic and Biosimilar Therapeutics?” and explains that biologic medicines are different than traditional chemical drugs, and present unique safety concerns to patients. Because of this fact the paper notes that in order to ensure patient-safety as biosimilars are approved in the U.S., they must be given unique, non-proprietary names.
Read the full article at Biosimilar News
November 29, 2012
The Alliance for Safe Biologic Medicines (“ASBM“), a self-described “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,” urges FDA in a new paper to adopt unique non-proprietary names for all biological products licensed under the Public Health Service Act (“PHS Act”), and in particular biosimilar versions of reference products (even those that are interchangeable).
Read full article at FDA Law Blog
