October 5, 2012
The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” on September 27, 2012 in Phoenix, AZ, to discuss the complex challenges the Food and Drug Administration (FDA) faces as it seeks to establish a regulatory pathway that will lead to the approval of biosimilars in the U.S.
October 2, 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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October 2, 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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October 1, 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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September 18, 2012
86% of physicians responding to a new US survey say they want to be notified before a patient is switched to a different biologic product than the one prescribed, even if there are no known concerns associated with it.
And 85% of physicians responding to the poll said that they want to have the authority to designate a biologic drug as “Dispensed as Written,” just as they have it for chemical drugs.
Read the full story.
September 18, 2012
86% of physicians responding to a new US survey say they want to be notified before a patient is switched to a different biologic product than the one prescribed, even if there are no known concerns associated with it.
And 85% of physicians responding to the poll said that they want to have the authority to designate a biologic drug as “Dispensed as Written,” just as they have it for chemical drugs.
Read the full story.
September 18, 2012
All biologic drugs, including biosimilars, should be required to have unique names to ensure their safety, the Alliance for Safe Biologic Medicines (ASBM) said Sept. 13.
ASBM released a survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution. ASBM said these policy issues remain unresolved and will have “a fundamental impact on patient safety.”
The 2010 health care reform law contains an abbreviated Food and Drug Administration approval pathway for generic biologic drugs, also called biosimilars. In February, FDA issued three draft guidance documents on biosimilar product development, focusing on scientific and quality considerations in demonstrating biosimilarity of a proposed product but giving little guidance on how these products should be named (10 PLIR 173, 2/10/12).
Survey Results
Sixty-four percent of the 350 physicians surveyed assume if products have the same name, a patient can be safely switched from one product to another during treatment, and more than 76 percent view products with the same scientific name as structurally identical, the survey said.
ASBM said inappropriate substitution is a major risk if different biologics have the same scientific name.
The vast majority (99 percent) of surveyed physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events, according to the survey. Additionally, less than 1 percent of surveyed prescribers use national drug code numbers for records or reporting.
Physicians also are concerned about a patient being switched from one biologic drug to another, ASBM said. Eighty-five percent of responding physicians want the authority to designate a biologic medicine as “dispensed as written,” just as they have for chemical products. Additionally, 86 percent 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.
“We have been very supportive of the FDA’s efforts to create a pathway that ensures biosimilars are safe and effective for patients,” Richard O. Dolinar, chairman of ASBM, said in a statement. “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.”
Unique Names Needed
Dolinar told BNA Aug. 20 in an interview that unique names are needed to be able to differentiate between the drugs. He said if unique names are not used and a patient experiences an adverse event, it would not be possible to determine what drug caused the adverse event. “It’s a safety issue,” Dolinar said.
“The first rule of medicine is to do no harm.” Dolinar said. “When doctors write orders they are meant to be followed exactly” and “in order to be precise you need unique names.”
“Physicians are concerned about the confusion caused by not having unique names,” Michael Reilly, executive director of ASBM, told BNA.
As the debate about unique names continues, stakeholders await more guidance from the agency.
Dolinar said he expects that FDA will come out with more guidance on biosimilar naming. Dolinar said the agency is “moving cautiously and asking for opinions” from different stakeholders on this issue.
ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include the branded biologic companies Amgen and Genentech.
The Pharmaceutical Research and Manufacturers of America (PhRMA) agrees that biosimilars need unique names. In comments submitted to FDA in May, PhRMA said “unique non-proprietary names are an essential feature of a robust system for adequately tracking adverse events.”
PhRMA said “it is critical to establish unique non-proprietary names for each biosimilar and biological product at the time of market entry regardless of the possibility of the biosimilar later seeking approval as an interchangeable biological product.”
Specifically, PhRMA said it supports a naming system that uses a common stem with a unique suffix. PhRMA suggested FDA consider a system like the one used in Japan, where biosimilar products in the same class share a common name plus a designation that it is a biosimilar plus a unique number that has been assigned to the biosimilar.
Generic Industry’s Perspective
In comments submitted to FDA in April on the draft guidances, the Generic Pharmaceutical Association said that biosimilars should be able to be tracked if there is a safety issue, but using unique individual nonproprietary names (INNs) would create safety problems.
GPhA said INNs “help inform health care providers as to the active ingredient in medicines, including biologics, and will help prevent double-dosing in the case of biosimilars IF the biosimilar shares the INN with its reference product.”
The generic industry group said that using different INNs for biosimilars “would create unique safety problems as physicians and other health care providers have every reason to expect that products that share active ingredients will share INNs, and so different INNs mean different active ingredients.”
GPhA said current systems in the United States do not require a unique INN “for effective track and trace of products” and “much of the track and trace of products is related to the reimbursement system and relies on the NDC number.” NDC stands for National Drug Code.
Pharmacy Groups Weigh In
In May, the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA) sent a letter to FDA on the draft biosimilar guidances (10 PLIR 747, 6/8/12). In the letter, the groups said biosimilars should have the same name as their reference biologic products.
“We are concerned that mandating the use of unique individual nonproprietary names (INNs) could create the very public health issues that the FDA wishes to avoid: therapeutic duplication and general confusion relative to the appropriate use, safety and efficacy of biologic products.”
The groups said the use of unique names “would increase the burden of being able to distinguish which products are biosimilar and interchangeable with which reference drug and may pose difficulties in recognizing the best alternative drug for therapeutic use in a timely manner.”
Additionally, the groups said using unique INNs would be contrary to the World Health Organization (WHO) naming system for drugs, which could cause confusion in the global marketplace.
“We acknowledge that the ability to uniquely identify which biological product a patient is taking is important, especially in cases of adverse events and quality issues,” the pharmacy groups said. “However, the use of INNs is not a warranted solution and may interfere with current pharmacy safety alert systems and complicate the collection of global safety information.”
The groups said a different unique identifier, such as an NDC code, could be used, which would allow pharmacies to track the specific drug that a patient is prescribed.
–Bronwyn Mixter
For More Information
The survey.
GPhA’s letter and the APhA, NACDS, NCPA letter.
Reproduced with permission from Pharmaceutical Law & Industry Report, 10 PLIR (Sept. 21, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>
September 18, 2012
All biologic drugs, including biosimilars, should be required to have unique names to ensure their safety, the Alliance for Safe Biologic Medicines (ASBM) said Sept. 13.
ASBM released a survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution. ASBM said these policy issues remain unresolved and will have “a fundamental impact on patient safety.”
The 2010 health care reform law contains an abbreviated Food and Drug Administration approval pathway for generic biologic drugs, also called biosimilars. In February, FDA issued three draft guidance documents on biosimilar product development, focusing on scientific and quality considerations in demonstrating biosimilarity of a proposed product but giving little guidance on how these products should be named (10 PLIR 173, 2/10/12).
Survey Results
Sixty-four percent of the 350 physicians surveyed assume if products have the same name, a patient can be safely switched from one product to another during treatment, and more than 76 percent view products with the same scientific name as structurally identical, the survey said.
ASBM said inappropriate substitution is a major risk if different biologics have the same scientific name.
The vast majority (99 percent) of surveyed physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events, according to the survey. Additionally, less than 1 percent of surveyed prescribers use national drug code numbers for records or reporting.
Physicians also are concerned about a patient being switched from one biologic drug to another, ASBM said. Eighty-five percent of responding physicians want the authority to designate a biologic medicine as “dispensed as written,” just as they have for chemical products. Additionally, 86 percent 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.
“We have been very supportive of the FDA’s efforts to create a pathway that ensures biosimilars are safe and effective for patients,” Richard O. Dolinar, chairman of ASBM, said in a statement. “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.”
Unique Names Needed
Dolinar told BNA Aug. 20 in an interview that unique names are needed to be able to differentiate between the drugs. He said if unique names are not used and a patient experiences an adverse event, it would not be possible to determine what drug caused the adverse event. “It’s a safety issue,” Dolinar said.
“The first rule of medicine is to do no harm.” Dolinar said. “When doctors write orders they are meant to be followed exactly” and “in order to be precise you need unique names.”
“Physicians are concerned about the confusion caused by not having unique names,” Michael Reilly, executive director of ASBM, told BNA.
As the debate about unique names continues, stakeholders await more guidance from the agency.
Dolinar said he expects that FDA will come out with more guidance on biosimilar naming. Dolinar said the agency is “moving cautiously and asking for opinions” from different stakeholders on this issue.
ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include the branded biologic companies Amgen and Genentech.
The Pharmaceutical Research and Manufacturers of America (PhRMA) agrees that biosimilars need unique names. In comments submitted to FDA in May, PhRMA said “unique non-proprietary names are an essential feature of a robust system for adequately tracking adverse events.”
PhRMA said “it is critical to establish unique non-proprietary names for each biosimilar and biological product at the time of market entry regardless of the possibility of the biosimilar later seeking approval as an interchangeable biological product.”
Specifically, PhRMA said it supports a naming system that uses a common stem with a unique suffix. PhRMA suggested FDA consider a system like the one used in Japan, where biosimilar products in the same class share a common name plus a designation that it is a biosimilar plus a unique number that has been assigned to the biosimilar.
Generic Industry’s Perspective
In comments submitted to FDA in April on the draft guidances, the Generic Pharmaceutical Association said that biosimilars should be able to be tracked if there is a safety issue, but using unique individual nonproprietary names (INNs) would create safety problems.
GPhA said INNs “help inform health care providers as to the active ingredient in medicines, including biologics, and will help prevent double-dosing in the case of biosimilars IF the biosimilar shares the INN with its reference product.”
The generic industry group said that using different INNs for biosimilars “would create unique safety problems as physicians and other health care providers have every reason to expect that products that share active ingredients will share INNs, and so different INNs mean different active ingredients.”
GPhA said current systems in the United States do not require a unique INN “for effective track and trace of products” and “much of the track and trace of products is related to the reimbursement system and relies on the NDC number.” NDC stands for National Drug Code.
Pharmacy Groups Weigh In
In May, the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA) sent a letter to FDA on the draft biosimilar guidances (10 PLIR 747, 6/8/12). In the letter, the groups said biosimilars should have the same name as their reference biologic products.
“We are concerned that mandating the use of unique individual nonproprietary names (INNs) could create the very public health issues that the FDA wishes to avoid: therapeutic duplication and general confusion relative to the appropriate use, safety and efficacy of biologic products.”
The groups said the use of unique names “would increase the burden of being able to distinguish which products are biosimilar and interchangeable with which reference drug and may pose difficulties in recognizing the best alternative drug for therapeutic use in a timely manner.”
Additionally, the groups said using unique INNs would be contrary to the World Health Organization (WHO) naming system for drugs, which could cause confusion in the global marketplace.
“We acknowledge that the ability to uniquely identify which biological product a patient is taking is important, especially in cases of adverse events and quality issues,” the pharmacy groups said. “However, the use of INNs is not a warranted solution and may interfere with current pharmacy safety alert systems and complicate the collection of global safety information.”
The groups said a different unique identifier, such as an NDC code, could be used, which would allow pharmacies to track the specific drug that a patient is prescribed.
–Bronwyn Mixter
For More Information
The survey.
GPhA’s letter and the APhA, NACDS, NCPA letter.
Reproduced with permission from Pharmaceutical Law & Industry Report, 10 PLIR (Sept. 21, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>
September 17, 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.
Names are the primary means of product identification for physicians.
Physicians are very concerned about a patient being switched from one biologic to another.
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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