Press Releases
ASBM Chairman: Patient Safety Key to Creating Global Biosimilar Standards
March 7th, 2013
WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) presented on March 5, 2013 at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C. Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.
“Creating global standards for biosimilars has to boil down to one thing – patient safety – no matter where in the world the biosimilars are approved,” said Dr. Dolinar. “To safely bring biosimilars to patients, we should build on the science-based approach taken by the European Union (EU) and establish quality standards regarding the approval process, approach to naming, and substitution policies.”
“There is much to be learned from the great progress that has already begun in the EU, Canada and other countries. ASBM is committed to supporting the efforts of the U.S. Food and Drug Administration in their mission to safely bring biosimilars to the U.S., and helping develop and endorse standards that will bring effective biologic and biosimilar treatments to patients across the world.”
View Dr. Dolinar’s full presentation here.
Biologics are used to treat cancer, diabetes, MS, 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 On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics.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.
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, biotechnology companies that develop innovative and biosimilar medicines 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.
Alliance for Safe Biologic Medicines Concerned Sequestration Cuts Could Delay Biosimilars Pathway
March 1st, 2013
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following:
“The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway for the approval of biosimilars. For the past year FDA employees have been working tirelessly to establish the pathway that will make these breakthrough medicines available to patients in the U.S.
“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.’
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 from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
Alliance for Safe Biologic Medicines Hosts Biosimilar Forum at University of Rhode Island, College of Pharmacy
December 21st, 2012
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.
Alliance for Safe Biologic Medicines, Colorado BioScience and the Biotechnology Industry Organization Host Biosimiars Forum in Colorado
December 10th, 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.
Alliance for Safe Biologic Medicines Responds to Updated EMA Q&A on Biosimilars
October 2nd, 2012
WASHINGTON – On September 27, 2012 the European Medicines Agency (EMA) released a revised version of their 2008 Question and Answer (Q&A) document differentiating the regulatory standards for biosimilar medicines from the standards used to support generic chemical medicines. ASBM Chairman Richard Dolinar, MD, released the following statement in recognition of the importance of that Q & A document:
“We see the changes the EMA made as a clear indication that Europe, and the EMA in particular, continue to distinguish between generics and biosimilars. As a practicing physician, I am pleased that the EMA have taken steps to guide the public to consult with both their physician and their pharmacist before making any changes to their medicines and recognize that biosimilar does not mean identical. We support their efforts to more clearly define the differences between biosimilars and generics.”
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.
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ASBM, ICAN and AZBio Discuss Patient Safety during Phoenix Forum
October 1st, 2012
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.
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ASBM Survey Reveals Key Safety Concern Associated with Biosimilar Naming; Urges Distinct Naming Requirement
September 17th, 2012
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today announced the results of a new survey on physician opinions relating to biologics and biosimilars. ASBM Chairman, Dr. Richard O. Dolinar, presented key findings during the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C., where he urged the FDA to make patient-safety the cornerstone of the biosimilars pathway.
The survey examined physician practices and perspectives with regard to biosimilar medicine identification and substitution – policy issues that remain unresolved and will have a fundamental impact on patient safety. Over 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists – all specialties that prescribe biologics – responded to the survey. Key findings from the physician survey demonstrate that patient safety must be a priority for all biosimilar policies.
Inappropriate substitution is a major risk if different biologics have the same scientific name.
- 64% of surveyed physicians assume if products have the same name a patient can be safely switched from one product to another during treatment.
- More than 76% view products with the same scientific name as structurally identical.
Names are the primary means of product identification for physicians.
- The vast majority (99%) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events.
- Less than 1% of prescribers use national drug code numbers for records or reporting.
Physicians are very concerned about a patient being switched from one biologic to another.
- 85% of responding physicians want the authority to designate a biologic medicine as “Dispensed as Written” just as they have it for chemical products.
- 86% of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.
Dr. Dolinar, chairman of the Alliance, released the following statement about the conference and the survey results:
“In the past 30 years, biologic medicines have revolutionized the treatment of patients with many diseases – but making copies of these highly complex medicines presents significant challenges for physicians and regulators. This survey provides important information for effectively addressing these challenges. Biologics are produced from living cells and copies will be only similar, not identical to the original. This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients.
“We have been very supportive of the FDA’s efforts to create a pathway that ensures biosimilars are safe and effective for patients. This survey demonstrates the potential safety consequences of giving different biologic products the same scientific name. In order to avoid inappropriate substitution, all biologics should be required to have distinct names.”
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 survey was conducted by Industry Standard Research. Read the ASBM Biosimilars Survey.
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.
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ASBM Advisory Board Members Urge FDA to Adopt Unique Names for Biosimilars
June 13th, 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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Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway
May 16th, 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.
Alliance for Safe Biologic Medicines Welcomes FDA Biosimilars Draft Guidance, Urges Cautious Approach to Ensure Patient Safety
April 16th, 2012
Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products
Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway.
While the FDA’s proposed framework demonstrates the agency’s thoughtful approach, ASBM stated in its comments that effective implementation of the biosimilars pathway must incorporate prudent measures, including:
- Analytical data and clinical studies to fully characterize the biosimilarity and immunogenicity of a biosimilar product;
- Traceability measures, including unique nonproprietary names for all biologic therapies, transparent product labels and patient/physician notification to enable clinical assessment and adverse event reporting; and
- Before designating a biosimilar ‘interchangeable’ with its reference product, U.S. regulators must recognize, and address, that the similarity between the reference product and its interchangeable biologic product(s) may change over time as a result of manufacturing or environmental variations.
Within its comment letter, the Alliance for Safe Biologic Medicines outlines clear, concrete, and achievable ways to manage risk and thereby prioritize patient safety.
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement as he submitted the coalition’s comments to the docket:
We are pleased with the FDA biosimilar draft guidance but it leaves a lot of questions unanswered — particularly when it comes to the requirement of clinical studies and pharmacovigilance.
There can be no grey area when it comes to patient safety. Unwanted immunogenicity is the preeminent safety challenge associated with biological therapeutics and can result in unexpected or sometimes severe adverse effects.
The predictive value of animal studies is often insufficient to characterize immunogenicity in humans. Clinical studies, in addition to analytical methods, are necessary to weed out ineffective and unsafe drugs — innovator biologics and biosimilars — before they are ever a risk to patients.
In the unfortunate situation that problems arise, measures must be in place to accurately and promptly connect a specific patient to a specific product. Our current pharmacovigilance system is not equipped to distinguish a biologic reference product from its biosimilars. Unique nonproprietary names for biosimilar and innovator compounds ensure we will be able to effectively track and trace a product to an adverse event. This must be implemented prior to biosimilar market entry.
The Alliance for Safe Biologic Medicines will continue to work with the FDA to outline an approval pathway that enables physicians to confidently prescribe biosimilar medicines.
On February 9, the FDA released draft guidance on the biosimilars approval pathway and requested written comments by April 16.
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