June 25, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety. Continue reading…
June 18, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety. Read the summary.
June 18, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety. Read the summary.
June 13, 2012
Physician’s Panel Says Patient Safety Undermined without Unique Names
WASHINGTON – In response to a recent letter by the National Coalition on Health Care on the issue of biosimilar naming, the Alliance for Safe Biologic Medicines (ASBM) and members of its National Advisory Board urge the U.S. Food and Drug Administration (FDA) to implement distinguishable nonproprietary names for all biosimilar products in order to ensure accurate prescribing, safe distribution and substitution and timely reporting of adverse events.
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement:
“ASBM recently convened a sub-group of our National Advisory Board to discuss some of the unique challenges physicians will face as the U.S. marketplace becomes more complicated with the arrival of biosimilars. Biologics can be highly sensitive to the manufacturing process and identifying specifically which product a patient received is essential to identifying any product-related adverse events. As practicing physicians we all agree that distinct names are a critical component of a strong track and trace system that will help ensure patient safety. While we believe that the National Coalition on Health Care is committed to patient safety, we are concerned that their recommended approach of using the same International Nonproprietary Names (INN) would lead to a weakened pharmacovigilance system that could put patients at risk.
“Uniquely identifiable names will more effectively enable tracking and tracing and product identification in the case of an adverse event than if a biologic product and its biosimilar versions from different manufacturers all share identical names.
“At the end of the day, distinguishable nonproprietary names are but one of a number of measures to protect patients and ensure that product problems do not become class problems due to a lack of traceability. Today, regulators in Thailand are struggling to attribute an increase in adverse events associated with a biologic medicine and are requiring re-evaluation of all approved dossiers and implementing new patient registries to reactively evaluate rates of occurrence. Here in the U.S., we have the opportunity to learn from foreign experiences and set sound policy. Along with distinguishable names, mandating transparent labels, distinctive packaging and discrete product codes for biologics and biosimilars will also enable more effective pharmacogivilance.”
Dr. Robert Yapundich, a practicing neurologist, who also participated in the sub-group discussion, added to Dr. Dolinar’s concerns.
“As a treating physician, my primary concern is the well-being of my patients and there is compelling evidence that distinct nonproprietary names for biosimilars are necessary for patient safety. In fact, distinguishable names may in some cases be the only means to trace an adverse event back to the product that caused it, especially among patients and physicians without access to a product code or lot number. Ultimately the physician community is confident that the FDA will require unique nonproprietary names in the interest of patient safety.”
To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.
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. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at www.safebiologics.org.
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May 17, 2012
Dr. Dolinar wrote an article for BIO’s May Newsletter on the FDA hearing and the importance of patient safety when creating a biosimilar pathway.
May 16, 2012
Prepared Remarks Identify Clinical Trials, Global Supply Chain, Unique Naming, Clear Packaging Information, and Interchangeability as Areas for Careful Consideration
WASHINGTON — Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on the U.S. drug market in prepared testimony for the FDA’s May 11th public hearing. The event addressed the FDA’s recent draft guidelines for the development of biosimilar products.
“We applaud the FDA’s efforts to bring biosimilars to the U.S. market, but would urge a deliberate approach that is becoming of FDA’s critical role of ensuring the safety and efficacy of the nation’s drug supply,” Dr. Dolinar said. “The members of the Alliance support the goal of the health care law to bring broader access to biologic medicines to patients across the country and we want to ensure that biosimilar medicines are as safe as the innovator drugs they seek to replicate.”
During his testimony, Dr. Dolinar, a practicing endocrinologist, outlined (1) the need for robust clinical testing; (2) the establishment of steps to monitor the global supply chain and manufacturing process; (3) the creation of track, trace and naming provisions; (4) the development of clear packaging, labeling and prescribing information; and (5) very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.
“Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes,” Dr. Dolinar said during his testimony. “For this reason, no two biologics made from different cell lines or using different processes can be identical based on today’s science. Biologics are also highly sensitive to the manufacturing process. In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body.”
Dr. Dolinar’s remarks to Dr. Rachel Sherman and other FDA panel members summarized the comments the Alliance submitted last month in response to the FDA’s draft guidance on the approval of biosimilar medicines. The Alliance’s written submission outlined clear, concrete and achievable ways to manage risk and prioritize patient safety.
To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.
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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. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at www.safebiologics.org.
May 16, 2012
After testifying before the FDA on May 11, Inside Health Policy quoted ASBM chairman Dr. Dolinar.
Biologics makers peg biosimilars areas they want clarified:
Alliance for Safe Biologics chairman Richard Dolinar said, “Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes. For this reason no two biologics made from different cell lines or using different processes can be identical based on today’s science. Biologics are also highly sensitive to the manufacturing process. In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body.”
May 16, 2012
ASBM chairman Dr. Richard Dolinar was quoted in a PharmaTimes article covering the May 11 FDA hearing on biosimilars.
From US FDA urged over biosimilars:
Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, outlined five areas of concern that he said the FDA should resolve before they allow biosimilars onto the US market. These are: – the need for robust clinical testing; – the establishment of steps to monitor the global supply chain and manufacturing process; – the creation of track, trace and naming provisions; – the development of clear packaging, labelling and prescribing information; and – very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.
“We applaud the FDA’s efforts to bring biosimilars to the US market, but would urge a deliberate approach that is becoming of FDA’s critical role of ensuring the safety and efficacy of the nation’s drug supply,” Dr Doliar told the hearing.
No two biologics made from different cell lines or using different processes can be identical based on today’s science, and they are also highly sensitive to the manufacturing process, said Dr Dolinar. “In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body,” he added.
May 16, 2012
ASBM chairman Dr. Richard Dolinar was quoted in a PharmaTimes article covering the May 11 FDA hearing on biosimilars.
From US FDA urged over biosimilars:
Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, outlined five areas of concern that he said the FDA should resolve before they allow biosimilars onto the US market. These are: – the need for robust clinical testing; – the establishment of steps to monitor the global supply chain and manufacturing process; – the creation of track, trace and naming provisions; – the development of clear packaging, labelling and prescribing information; and – very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.
“We applaud the FDA’s efforts to bring biosimilars to the US market, but would urge a deliberate approach that is becoming of FDA’s critical role of ensuring the safety and efficacy of the nation’s drug supply,” Dr Doliar told the hearing.
No two biologics made from different cell lines or using different processes can be identical based on today’s science, and they are also highly sensitive to the manufacturing process, said Dr Dolinar. “In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body,” he added.
April 19, 2012
The Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA outlining recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway. Read the ASBM Comments.
