A Picture is worth a thousand words… Why Memorable Names are preferred by Pharmacists
by Philip Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair
Yesterday, I was in Philadelphia with a group of about 50 pharmacy students and faculty speaking about biosimilars and the role they do play and will play in our healthcare system. I explained the differences between a biosimilar and a generic, and why it is important to understand these differences as we develop policy around the substitution and naming of biosimilars. After discussing the FDA’s evolving policy towards naming, I asked those in the room whether it made sense to have a memorable name as was used for the first biosimilar approved by the FDA (zarxio-sndz) with the suffix representing the manufacturer’s name, or a random name like that used for the second FDA approved biosimilar (infliximab-dyyb). Not surprisingly, a single hand went up supporting the random approach. I have conducted similar educational forums on biosimilars over the past few years and have consistently seen that pharmacists overwhelmingly support memorable names. If we could just get that message to the organizations that represent pharmacists, we would all be better served.
A Picture is worth a thousand words… Why Memorable Names are preferred by Pharmacists
by Philip Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair
Yesterday, I was in Philadelphia with a group of about 50 pharmacy students and faculty speaking about biosimilars and the role they do play and will play in our healthcare system. I explained the differences between a biosimilar and a generic, and why it is important to understand these differences as we develop policy around the substitution and naming of biosimilars. After discussing the FDA’s evolving policy towards naming, I asked those in the room whether it made sense to have a memorable name as was used for the first biosimilar approved by the FDA (zarxio-sndz) with the suffix representing the manufacturer’s name, or a random name like that used for the second FDA approved biosimilar (infliximab-dyyb). Not surprisingly, a single hand went up supporting the random approach. I have conducted similar educational forums on biosimilars over the past few years and have consistently seen that pharmacists overwhelmingly support memorable names. If we could just get that message to the organizations that represent pharmacists, we would all be better served.
On Friday, July 22nd, The Alliance for Safe Biologic Medicines and MedChi, the Maryland State Medical Society co-hosted a forum entitled “Biosimilars: New Choices, New Challenges”. The event was attended by more than 45 physicians, legislators, patient advocates, healthcare workers, and others.
MedChi’s CEO, Gene Ransom III began the forum with a discussion of the importance of biosimilars in bringing new treatment options to patients. Mr. Ransom demonstrated MedChi’s knowledge of biosimilar issues, and detailed the organization’s history of advocacy for transparency in biosimilar naming and labeling, providing examples of MedChi’s work in urging FDA to support these policies.
Mr. Ransom gives examples of MedChi’s previous advocacy to the FDA in support of distinguishable naming for biosimilars.
In regard to biosimilar substitution, Mr. Ransom discussed MD Senate Bill 0537, which MedChi supported. SB 0537, like substitution bills in many states, requires a pharmacist to communicate to the prescribing physician within 5 days which product- the originator or the biosimilar- was dispensed. The bill passed the Maryland Senate 46-0, but died in the House Committee on Healthcare.
MedChi CEO Gene Ransom III discusses several recent policy issues on which his organization has engaged on behalf of Maryland’s physicians.
ASBM Chairman, Harry L Gewanter, MD then presented a brief overview of biosimilars. He discussed the benefits they can bring to patients, and how their differences from generic versions of chemical drugs (which do copy their reference products identically) create several policy challenges which must be addressed in order for patients to realize those benefits.
ASBM’s surveys of biologic prescribers in eleven countries have aided the World Health Organization in the development of its distinguishable naming system, Dr. Gewanter explains.
First among these are biologic naming. Echoing MedChi’s concerns, Dr. Gewanter emphasized that clear product identification is critical when prescribing, dispensing, and tracking efficacy of all biologic medicines. Dr. Gewanter discussed the naming systems proposed by the FDA and WHO. Dr. Gewanter shared data from ASBM’s surveys of biologic prescribers in eleven countries which show strong and widespread support for distinct naming. In the U.S., 66% of biologic prescribers support the FDA issuing distinct names for all biologics, including biosimilars.
In order to be classified a biosimilar, a medicine must be highly similar to its reference product, and their differences not clinically meaningful.
Regarding biosimilar substitution, Dr. Gewanter showed data from ASBM’s survey of 400 U.S. physicians which revealed that MedChi’s concerns were shared by most physicians. 80% considered it “very important or critical” for a pharmacist to communicate to them when a biosimilar has been substituted at the pharmacy. 82% considered it “very important or critical” to have the authority to block a substitution they deem inappropriate for their patient by indicating “Dispense As Written (DAW)” on the prescription.
Dr. Gewanter explains physician concerns with the prospect of automatic substitution of biosimilars by a pharmacist- substitution of a biosimilar for the prescribed biologic without physician knowledge or involvement.
Dr. Gewanter’s presentation may be viewed here.
ASBM’s Advisory Board Chair, Philip Schneider, Professor and Associate Dean at the University of Arizona’s College of Pharmacy then provided the pharmacist perspective on biosimilars.
Regarding naming, Dean Schneider discussed the long tradition of pharmacists avoiding look-alike or sound-alike names for different medications. Dr. Schneider also noted that while national pharmacy societies such as the American Pharmacist Association (APhA) and the American Society of Health-system Pharmacists (ASHP), (of which Dr. Schneider is a past president) have expressed skepticism, rank-and-file pharmacists have generally been supportive of distinct naming . An ASBM poll of 401 U.S. pharmacists revealed that 68% support the FDA distinct names for all biologics, including biosimilars.
Following initial resistance to communication provisions in the substitution bills in several states, pharmacist perspectives have shifted somewhat, Dr. Schneider explained. The issue has largely faded as a matter of debate among national pharmacy societies, for example.
Finally, Dr. Schneider raised the issue of transparency in biosimilar labeling. ASBM surveys of physicians and pharmacists show these healthcare providers want more informative and transparent labeling than is currently required by the FDA’s Draft Guidance on Labeling of Biosimilars:
The final speaker was Andrew Spiegel, Executive Director of the Global Colon Cancer Association, who gave a patient perspective on biologics and biosimilars.
Mr. Spiegel praised biologic medicines for their role in tripling the life expectancy of patients diagnosed with colon cancer. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.
Mr. Spiegel described his experience at recent FDA hearings, where committee members were given an “all or nothing” choice: approve a biosimilar for all the diseases it seeks approval to treat (or indications) for which it applied, or none at all. By contrast, in Canada, biosimilars are approved for each indication separately. The FDA’s “all or nothing” approach is worrying, and does not serve the interest of patients, Mr. Spiegel argued.
The treatment decision-including when to use or switch to a biosimilar- should always remain with the patient and his healthcare team, said Mr. Spiegel.
Finally, Mr. Spiegel raised the emerging issue of Non-Medical Switching. The choice to use an innovator biologic or biosimilar, must always be made by the patient and those who provide him direct care, rather than a third-party payer.
“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.
On Friday, July 22nd, The Alliance for Safe Biologic Medicines and MedChi, the Maryland State Medical Society co-hosted a forum entitled “Biosimilars: New Choices, New Challenges”. The event was attended by more than 45 physicians, legislators, patient advocates, healthcare workers, and others.
MedChi’s CEO, Gene Ransom III began the forum with a discussion of the importance of biosimilars in bringing new treatment options to patients. Mr. Ransom demonstrated MedChi’s knowledge of biosimilar issues, and detailed the organization’s history of advocacy for transparency in biosimilar naming and labeling, providing examples of MedChi’s work in urging FDA to support these policies.
Mr. Ransom gives examples of MedChi’s previous advocacy to the FDA in support of distinguishable naming for biosimilars.
In regard to biosimilar substitution, Mr. Ransom discussed MD Senate Bill 0537, which MedChi supported. SB 0537, like substitution bills in many states, requires a pharmacist to communicate to the prescribing physician within 5 days which product- the originator or the biosimilar- was dispensed. The bill passed the Maryland Senate 46-0, but died in the House Committee on Healthcare.
MedChi CEO Gene Ransom III discusses several recent policy issues on which his organization has engaged on behalf of Maryland’s physicians.
ASBM Chairman, Harry L Gewanter, MD then presented a brief overview of biosimilars. He discussed the benefits they can bring to patients, and how their differences from generic versions of chemical drugs (which do copy their reference products identically) create several policy challenges which must be addressed in order for patients to realize those benefits.
ASBM’s surveys of biologic prescribers in eleven countries have aided the World Health Organization in the development of its distinguishable naming system, Dr. Gewanter explains.
First among these are biologic naming. Echoing MedChi’s concerns, Dr. Gewanter emphasized that clear product identification is critical when prescribing, dispensing, and tracking efficacy of all biologic medicines. Dr. Gewanter discussed the naming systems proposed by the FDA and WHO. Dr. Gewanter shared data from ASBM’s surveys of biologic prescribers in eleven countries which show strong and widespread support for distinct naming. In the U.S., 66% of biologic prescribers support the FDA issuing distinct names for all biologics, including biosimilars.
In order to be classified a biosimilar, a medicine must be highly similar to its reference product, and their differences not clinically meaningful.
Regarding biosimilar substitution, Dr. Gewanter showed data from ASBM’s survey of 400 U.S. physicians which revealed that MedChi’s concerns were shared by most physicians. 80% considered it “very important or critical” for a pharmacist to communicate to them when a biosimilar has been substituted at the pharmacy. 82% considered it “very important or critical” to have the authority to block a substitution they deem inappropriate for their patient by indicating “Dispense As Written (DAW)” on the prescription.
Dr. Gewanter explains physician concerns with the prospect of automatic substitution of biosimilars by a pharmacist- substitution of a biosimilar for the prescribed biologic without physician knowledge or involvement.
Dr. Gewanter’s presentation may be viewed here.
ASBM’s Advisory Board Chair, Philip Schneider, Professor and Associate Dean at the University of Arizona’s College of Pharmacy then provided the pharmacist perspective on biosimilars.
Regarding naming, Dean Schneider discussed the long tradition of pharmacists avoiding look-alike or sound-alike names for different medications. Dr. Schneider also noted that while national pharmacy societies such as the American Pharmacist Association (APhA) and the American Society of Health-system Pharmacists (ASHP), (of which Dr. Schneider is a past president) have expressed skepticism, rank-and-file pharmacists have generally been supportive of distinct naming . An ASBM poll of 401 U.S. pharmacists revealed that 68% support the FDA distinct names for all biologics, including biosimilars.
Following initial resistance to communication provisions in the substitution bills in several states, pharmacist perspectives have shifted somewhat, Dr. Schneider explained. The issue has largely faded as a matter of debate among national pharmacy societies, for example.
Finally, Dr. Schneider raised the issue of transparency in biosimilar labeling. ASBM surveys of physicians and pharmacists show these healthcare providers want more informative and transparent labeling than is currently required by the FDA’s Draft Guidance on Labeling of Biosimilars:
The final speaker was Andrew Spiegel, Executive Director of the Global Colon Cancer Association, who gave a patient perspective on biologics and biosimilars.
Mr. Spiegel praised biologic medicines for their role in tripling the life expectancy of patients diagnosed with colon cancer. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.
Mr. Spiegel described his experience at recent FDA hearings, where committee members were given an “all or nothing” choice: approve a biosimilar for all the diseases it seeks approval to treat (or indications) for which it applied, or none at all. By contrast, in Canada, biosimilars are approved for each indication separately. The FDA’s “all or nothing” approach is worrying, and does not serve the interest of patients, Mr. Spiegel argued.
The treatment decision-including when to use or switch to a biosimilar- should always remain with the patient and his healthcare team, said Mr. Spiegel.
Finally, Mr. Spiegel raised the emerging issue of Non-Medical Switching. The choice to use an innovator biologic or biosimilar, must always be made by the patient and those who provide him direct care, rather than a third-party payer.
“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.
On July 12th and 13th, the FDA’s Arthritis Advisory Committee, held two meetings, to discuss proposed biosimilars to adalimumab (July 12th) and etanercept (July 13th).
Nine ASBM members provided oral or written testimony at one or both of the meetings.
Many of those testifying expressed concern with the FDA’s practice of approving biosimilars in indications in which they were not clinically evaluated, based on extrapolation from clinical data in other indications. Said ASBM’s Chairman Harry Gewanter, MD, in a statement:
“We believe the approval of a biosimilar should be decided on a case-by-case basis for each potential indication based on sufficient supporting data rather than justifying an automatic blanket extrapolation to all indications. Ultimately, the burden of proof must be on the biosimilar manufacturer to demonstrate that their product is highly similar in structure, function and in patient response to the reference product.”
Andrew Spiegel, Executive Director of the Global Colon Cancer Association (an ASBM Steering Committee Member), expressed concerns with the approval process in his statement:
“Extrapolation is also an area of concern to the patient community. At a minimum, approval for each indication should be granted individually, rather than an all-or-nothing approach. We don’t suggest that safe extrapolation is not possible, we simply think each indication should be approved individually based on solid data. This panel should have flexibility, and not be forced to approve the drug for all or no indications.”
Mr. Spiegel cited the more cautious approach taken by Health Canada to approve a biosimilar to infliximab. While approved for Rheumatoid Arthritis (RA) and Ankylosing Spondilitis (AS), additional clinical data was required before approval was granted for IBD indications (Ulcerative Colitis and Crohn’s Disease) two years later.
Mr. Spiegel also joined other patient advocates in urging the FDA to oppose the practice of Non-Medical Switching, particularly with non-interchangeable biosimilars:
“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel.
NMS is the switching of a patient from one treatment to another, typically by a third party such as a Pharmacy Benefit Manager (PBM) or insurance company, for reasons other than a patient’s health and safety.
Unlike generic versions of chemical drugs, biosimilars are not identical to their reference products, and these differences can produce unexpected effects in patients, including unwanted and harmful immune responses. In the case of biologic treatments such as those used to treat autoimmune disorders, switching a patient (who may have worked for years to find a treatment that effectively manages his or her condition) can cause the patient to lose that hard-won stability.
NMS is the switching of a patient from one treatment to another, typically by a third party such as a Pharmacy Benefit Manager (PBM) or insurance company, for reasons other than a patient’s health and safety.
Unlike generic versions of chemical drugs, biosimilars are not identical to their reference products, and these differences can produce unexpected effects in patients, including unwanted and harmful immune responses. In the case of biologic treatments such as those used to treat autoimmune disorders, switching a patient (who may have worked for years to find a treatment that effectively manages his or her condition) can cause the patient to lose that hard-won stability.
ASBM was an exhibitor during the 52nd Annual meeting of the Drug Information Association (DIA) held June 26th-30th in Philadelphia.
ASBM members and staff discussed biosimilars policy with attendees, including the need for the FDA to maintain high standards for safety and efficacy when approving biosimilars.
More than 65 attendees, including clinical researchers, physicians, pharmacists, patients, and regulators, filled out “Names Matter” postcards urging the FDA to adopt meaningful, memorable suffixes in future biosimilar approvals (as it did in its first approval) rather than random suffixes (as it did in its second).
ASBM’s booth at DIA 2016
ASBM’s Executive Director, Michael Reilly was in attendance and discussed biosimilar policy with other conference attendees.
DIA 2016 attendees filled out postcards urging the FDA to adopt meaningful, memorable suffixes for biosimilars.
John Lewis, VP of Communications for the Association of Clinical Research Organizations (ACRO), fills out a postcard.
ASBM also promoted the benefits of meaningful, memorable biologic naming through multiple table advertisements in the refreshment area.
On June 29th, ASBM Chairman Harry L. Gewanter, MD and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave presentations at the 6th Latin American Forum on Biosimilars, held in Brasília, Brazil. The event was also the 7th Brazilian Forum on Biosimilars. The event was attended by more than 500 healthcare stakeholders, including patients, physicians, regulators and manufacturers.
Dr. Gewanter presented data from ASBM’s survey of 399 Latin American prescribers of biologic medicines, on matters including biosimilar naming, labeling, and substitution.
The survey found a need for education about biosimilars among the physicians surveyed, all of whom prescribe biologics. Only 12% of respondents considered themselves “very familiar” with biosimilars, with more than a third (35%) having never heard of them or being unable to define the term.
Dr. Gewanter discussed two distinguishable biologic naming proposals by the FDA and World Health Organization (WHO) that would ensure clear product identification between similar medicines, allow an accurate patient record to be kept, and promote accurate tracking of adverse events.
The survey showed that 94% of respondents considered the WHO’s proposal, a four-letter suffix called a “biological qualifier” or BQ, “helpful” in ensuring their patients receive the correct medicine.
Mr. Spiegel presented the patient perspective on biosimilars, emphasizing the need for high and consistent approval standards, transparency in labeling and during substitution, and the importance of control of treatment decisions remaining between a patient and his healthcare team from whom he or she receives direct care.
Mr. Spiegel cautioned against the non-medical switching of a patient’s medicine, arguing that there is no reason for a physician to switch a medicine that is working effectively for a patient. The patient’s health and safety should always be the primary consideration.
On June 29th, ASBM Chairman Harry L. Gewanter, MD and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave presentations at the 6th Latin American Forum on Biosimilars, held in Brasília, Brazil. The event was also the 7th Brazilian Forum on Biosimilars. The event was attended by more than 500 healthcare stakeholders, including patients, physicians, regulators and manufacturers.
Dr. Gewanter presented data from ASBM’s survey of 399 Latin American prescribers of biologic medicines, on matters including biosimilar naming, labeling, and substitution.
The survey found a need for education about biosimilars among the physicians surveyed, all of whom prescribe biologics. Only 12% of respondents considered themselves “very familiar” with biosimilars, with more than a third (35%) having never heard of them or being unable to define the term.
Dr. Gewanter discussed two distinguishable biologic naming proposals by the FDA and World Health Organization (WHO) that would ensure clear product identification between similar medicines, allow an accurate patient record to be kept, and promote accurate tracking of adverse events.
The survey showed that 94% of respondents considered the WHO’s proposal, a four-letter suffix called a “biological qualifier” or BQ, “helpful” in ensuring their patients receive the correct medicine.
Mr. Spiegel presented the patient perspective on biosimilars, emphasizing the need for high and consistent approval standards, transparency in labeling and during substitution, and the importance of control of treatment decisions remaining between a patient and his healthcare team from whom he or she receives direct care.
Mr. Spiegel cautioned against the non-medical switching of a patient’s medicine, arguing that there is no reason for a physician to switch a medicine that is working effectively for a patient. The patient’s health and safety should always be the primary consideration.
