On June 28th, ASBM Chairman Harry L. Gewanter, MD presented to an audience of 150 at the 8th Latin American Biosimilars Forum in Brasilia, Brazil.
In his presentation, entitled “Increasing Physician Confidence in Biosimilars”, Dr. Gewanter discussed barriers to widespread acceptance of biosimilars among physicians.
Dr. Gewanter discusses how physician surveys can be used by regulators to promote policies which increase physician confidence in biosimilars.
Dr. Gewanter cited the example of Australia, where biosimilar uptake remains low due to a lack of clinical and post-market data that would build physician confidence and increase biosimilar usage. He went on to urge regulators to adopt other policies which build physician confidence, such as embracing the WHO’s distinct naming proposal and requiring informative and transparent labeling of biosimilars.
ASBM was represented in the Australian Pavilion by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Alliance. Dean Schneider and Mr. Spiegel distributed summaries of survey findings from ASBM’s survey of Australian biologic prescribers.
Both met with Australian regulators and government officials to discuss the findings, and how to address physician concerns to improve biosimilar uptake in Australia.
ASBM Advisory Board Chair Philip J Schneider meets with The Hon. Leaanne Enoch, Member of Australian Parliament, in the Australian Pavilion.
The issue of non-medical switching, a contentious issue within Australia, was also discussed widely in the Pavilion.
Mr. Spiegel was also invited to speak at the bilateral meeting with the South Africans to discuss emerging issues on biologics and biosimilar issues at the BIO Convention.
Dr. Gewanter presents a poster based on findings from ASBM’s recent survey of Australian prescribers of biologics.
On June 20th, ASBM Chairman Harry L. Gewanter, MD presented a poster based on ASBM’s survey of Australian biologic prescribers, at the DIA 2017 Annual Meeting in Chicago, IL. ASBM exhibited at DIA from June 19th-21st.
Dr. Gewanter answers questions from conference attendees at the ASBM booth, as well as distributing literature and promotional syringe pens.
The survey included 76% of prescribers believed the Therapeutic Goods Administration (TGA) should assign distinct names to all biologics, including biosimilars.
Also, 90% considered it “very important” or “critical” that the prescribing physician, with their patient, have the authority to choose the most suitable biologic for treatment. Eighty-nine percent considered it “very important” or “critical” to be notified in the event a biosimilar is substituted at the pharmacy.
Dr. Gewanter presents a poster based on findings from ASBM’s recent survey of Australian prescribers of biologics.
On June 20th, ASBM Chairman Harry L. Gewanter, MD presented a poster based on ASBM’s survey of Australian biologic prescribers, at the DIA 2017 Annual Meeting in Chicago, IL. ASBM exhibited at DIA from June 19th-21st.
Dr. Gewanter answers questions from conference attendees at the ASBM booth, as well as distributing literature and promotional syringe pens.
The survey included 76% of prescribers believed the Therapeutic Goods Administration (TGA) should assign distinct names to all biologics, including biosimilars.
Also, 90% considered it “very important” or “critical” that the prescribing physician, with their patient, have the authority to choose the most suitable biologic for treatment. Eighty-nine percent considered it “very important” or “critical” to be notified in the event a biosimilar is substituted at the pharmacy.
If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe and effective and as a result, physicians have complete confidence in them.
The suggestion of zero safety concerns is a particularly bold claim, and one unsupported by robust post marketing data for approved biosimilars. Those promoting biosimilars argue that the lack of adverse event data is proof that biosimilars are working well. However, physicians consistently say that the absence of data is not proof of anything but the lack of data. For example, in 2016 the Australian Rheumatology Association (ARA) called for the Department of Health to institute a post-market surveillance program for biosimilars, with data collection ability. As ARA biosimilars lead Dr. Mona Marabani explains, “The ARA wants to see biosimilars successfully introduced to the Australian market but we have expressed concern with respect to substitution and extrapolation of indications … we are hopeful that collection of data, if done comprehensively, may go some way to establishing an evidence base which is so sorely needed.”
The Alliance for Safe Biologic Medicines (ASBM) has conducted surveys of biologic prescribers in 12 countries regarding their knowledge, use and confidence of biosimilars and the results have consistently indicated a reluctance to switch from biologics to biosimilars that comes mostly from a lack of familiarity and post-marketing data.
Of great interest to these policymakers was that the majority of Australia’s biologic prescribers wanted to see data demonstrating three safe switches between a biosimilar and its reference product — without safety issues or loss of efficacy — before permitting it to be substituted by a government payer. (This is similar to proposed FDA requirements a biosimilar must meet in order to be substituted by a pharmacist)
Interestingly, the Austrailian physician survey revealed that 65 percent of prescribers did not consider loss of efficacy a reportable adverse event — meaning the loss would likely go unreported. Would European physicians report reduced efficacy if it occurred with a biosimilar? We simply don’t know. The absence of data is not data.
Far from the headline suggesting total success, Europe’s legacy on biosimilars has been mixed — its early advances offset by many missed opportunities — including the lost chance to have built physician and patient confidence in biosimilars worldwide with 11 years of solid post-marketing data. The lack of uptake of biosimilars in the EU due to this missed opportunity is the real headline.
Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. Mr. Reilly worked in the Office of the Secretary at the U.S. Department of Health and Human Services from 2002-2008.All ASBM surveys may be viewed at www.safebiologics.org/surveys.
A version of this article appeared in BioTechDaily News June 19, 2017
If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe and effective and as a result, physicians have complete confidence in them.
The suggestion of zero safety concerns is a particularly bold claim, and one unsupported by robust post marketing data for approved biosimilars. Those promoting biosimilars argue that the lack of adverse event data is proof that biosimilars are working well. However, physicians consistently say that the absence of data is not proof of anything but the lack of data. For example, in 2016 the Australian Rheumatology Association (ARA) called for the Department of Health to institute a post-market surveillance program for biosimilars, with data collection ability. As ARA biosimilars lead Dr. Mona Marabani explains, “The ARA wants to see biosimilars successfully introduced to the Australian market but we have expressed concern with respect to substitution and extrapolation of indications … we are hopeful that collection of data, if done comprehensively, may go some way to establishing an evidence base which is so sorely needed.”
The Alliance for Safe Biologic Medicines (ASBM) has conducted surveys of biologic prescribers in 12 countries regarding their knowledge, use and confidence of biosimilars and the results have consistently indicated a reluctance to switch from biologics to biosimilars that comes mostly from a lack of familiarity and post-marketing data.
Of great interest to these policymakers was that the majority of Australia’s biologic prescribers wanted to see data demonstrating three safe switches between a biosimilar and its reference product — without safety issues or loss of efficacy — before permitting it to be substituted by a government payer. (This is similar to proposed FDA requirements a biosimilar must meet in order to be substituted by a pharmacist)
Interestingly, the Austrailian physician survey revealed that 65 percent of prescribers did not consider loss of efficacy a reportable adverse event — meaning the loss would likely go unreported. Would European physicians report reduced efficacy if it occurred with a biosimilar? We simply don’t know. The absence of data is not data.
Far from the headline suggesting total success, Europe’s legacy on biosimilars has been mixed — its early advances offset by many missed opportunities — including the lost chance to have built physician and patient confidence in biosimilars worldwide with 11 years of solid post-marketing data. The lack of uptake of biosimilars in the EU due to this missed opportunity is the real headline.
Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. Mr. Reilly worked in the Office of the Secretary at the U.S. Department of Health and Human Services from 2002-2008.All ASBM surveys may be viewed at www.safebiologics.org/surveys.
A version of this article appeared in BioTechDaily News June 19, 2017
ASBM Chairman Harry L. Gewanter MD and ASBM Steering Committee Member Andrew Spiegel, head of the Global Colon Cancer Association, staff a shared booth at ASCO 2017 in Chicago.
On June 3-5th, ASBM exhibited at the American Society of Clinical Oncologists (ASCO) Annual Meeting in Chicago, IL. There ASBM Chairman Harry L. Gewanter, MD spoke with many physicians, patient advocates and manufacturers about ASBM’s worldwide advocacy on behalf of patients. ASBM shared a booth with Steering Committee member Global Colon Cancer Association, represented by its Executive Director, Andrew Spiegel. Several other ASBM member groups exhibited as well including: the Kidney Cancer Association (KCA), and the International Cancer Advocacy Network (ICAN).
ASBM Advisory Board Chair Philip J. Schneider, Associate Dean of the University of Arizona College of Pharmacy, staffs ASBM’s booth at the ASHP Summer Meeting.
On June 4th-6th, ASBM also exhibited at the American Society of Health System Pharmacists (ASHP) 2017 Summer Meeting in Minneapolis, MN. ASBM Advisory Board Chair Philip Schneider (a past president of ASHP) was at ASBM’s booth.
Dean Schneider visited with many pharmacists from hospitals and health systems nationwide discussing ASBM’s work with the WHO and state governments regarding clear product identification and improved pharmacovigilance. A video aimed at pharmacists, featuring Schneider and fellow Advisory Board member Ronald P. Jordan, Dean of Chapman University’s School of Pharmacy (past president of the American Pharmacists Association), was presented in ASBM’s booth throughout the conference.
On June 6th, ASBM sent a letter to national health regulatory authorities in 20 countries. The letter explains the benefits of distinct names for biologic medicines and ask regulators in different countries to urge the World Health Organization (WHO) to make its Biological Qualifier (BQ) system available to countries who wish to extend its benefits to their patients.
From the ASBM letter:
ASBM believes that implementation of BQ suffixes is a global solution to the global problem of biologic naming and could potentially become a global system for pharmacovigilance for all biologic medicines and that it should be implemented before further proliferation of national naming schemes.
ASBM urges (national regulator) to consider requesting that WHO make available the BQ suffix system for all approved biologic medicines as part of a worldwide effort to ensure robust pharmacovigilance through distinguishable naming.
Letters were sent to the national regulatory agencies of: Australia, Canada, Germany, Greece, India, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, the United Kingdom, and the United Arab Emirates.
On June 6th, ASBM sent a letter to national health regulatory authorities in 20 countries. The letter explains the benefits of distinct names for biologic medicines and ask regulators in different countries to urge the World Health Organization (WHO) to make its Biological Qualifier (BQ) system available to countries who wish to extend its benefits to their patients.
From the ASBM letter:
ASBM believes that implementation of BQ suffixes is a global solution to the global problem of biologic naming and could potentially become a global system for pharmacovigilance for all biologic medicines and that it should be implemented before further proliferation of national naming schemes.
ASBM urges (national regulator) to consider requesting that WHO make available the BQ suffix system for all approved biologic medicines as part of a worldwide effort to ensure robust pharmacovigilance through distinguishable naming.
Letters were sent to the national regulatory agencies of: Australia, Canada, Germany, Greece, India, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, the United Kingdom, and the United Arab Emirates.
On May 30th, in partnership with the Connecticut State Medical Society, ASBM presented a 2-hour Continuing Medical Education (CME) course entitled “Biosimilars: New Choices, New Challenges”.
CSMS President Jeff Gordon, MD speaks about the need for physicians to educate themselves on biosimilars and engage on policy making that will affect their practice.
The event began with remarks by CSMS President Jeff Gordon, MD, who is Medical Director of Hematology-Oncology Services at Day-Kimball Hospital in Putnam, CT. Dr. Gordon emphasized the great excitement about biosimilars among physicians, and the importance of physician engagement as biosimilar policy is being created. As an example, he cited CT House Bill 7118 (HB 7118), which recently passed the Connecticut House of Representatives with the support of CSMS. Like similar laws enacted in 35 states and Puerto Rico, HB 7118 would permit Connecticut pharmacists to substitute an FDA-approved “interchangeable” biosimilar, provided they inform the prescribing physician within 72 hours of the substitution. Physicians need to know what medicine the patient receives in order to better monitor their treatment, explained Dr. Gordon.
ASBM Chairman Harry L. Gewanter, MD
ASBM Chairman Harry L. Gewanter MD then presented. He began with a brief recap about what makes biologics different than small-molecule drugs, and what makes biosimilars different from chemical generics. These fundamental differences including greater size and complexity and potential for immune responses, Dr. Gewanter explained, necessitate a different regulatory approach than for generic drugs. For example, he highlighted how regulators including the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) have proposed distinct naming for all biologics, including biosimilars, by use of a four-letter suffix appended to the nonproprietary name. This would ensure clear product identification, lessening the chance of inadvertent substitution, ensuring the accurate attribution of adverse events, and promoting manufacturer accountability for their products.
Dr. Gewanter shared results from ASBM’s surveys of biologic prescribers in 12 countries, showing strong support for distinct naming among respondents, ranging from 66%-94% depending on the country. U.S. pharmacists surveyed shared this sentiment, with 68% supporting distinct naming.
Dr. Gewanter discusses biosimilar labeling in the U.S., including what information physicians and pharmacists consider important to include.
Dr. Gewanter also addressed the issue of product labeling, sharing survey data from US physicians and pharmacists which revealed these practitioners want more informative, transparent labeling than is currently required by the FDA, especially regarding indication extrapolation and whether or not the biosimilar is interchangeable with its reference product. He offered Health Canada’s labeling guidance as an example of suitable transparency to which other regulators including the FDA should look as a model.
Dr. Gewanter discusses substitution and interchangeability policy.
Bringing things full circle to Dr. Gordon’s remarks about HB 7118, Dr. Gewanter shared ASBM survey data regarding prescriber attitudes on substitution. Between 77%-89% of physicians in the 12 countries surveyed consider it “very important” or “critical” that they be notified in the event of a biosimilar substitution. This requirement is a key provision in HB 7118 and in the biosimilar substitution laws enacted by 35 states and Puerto Rico.
Andrew Spiegel, Executive Director of the Global Colon Cancer Association
Next, Andrew Spiegel, Executive Director of the Global Colon Cancer Association, an ASBM Steering Committee Member, presented the patient perspective on biosimilars. Mr. Spiegel spoke of the great enthusiasm patients have for biosimilars, citing the role biologics have played in extending the lives of colorectal cancer patients. Mr. Spiegel also emphasized the need for the biosimilar approval process be transparent to patients and physicians, and for manufacturers to provide ample data demonstrating the safety of their products. This, Mr. Spiegel argued, will serve to increase patient and physician confidence in biosimilars.
Andrew Spiegel explains how data and transparency are the key to building patient and physician confidence in biosimilars.
Mr. Spiegel then spoke on the subject of Non-Medical Switching (NMS). NMS is when an private insurer, government payer, or other third party switches a patient’s medicine for reasons other than the patient’s health and safety. Mr. Spiegel outlined a number of ways patients can be forced to switch therapies, including raising out of pocket costs (coinsurance, copay, etc.) for a patient’s current therapy, formulary design changes, changing tiers, and blocking the use of co-pay cards.
Finally, Mr. Spiegel discussed the need for treatment decisions, including the decision to switch to a biosimilar, to remain between a patient and their physician. Many patients struggle for years to become stable, trying several different medications. Changing a patient’s medicine can result in loss of this hard-won stability, Spiegel explained. To highlight these concerns, he showed showing this video from ASBM Member Kathleen Arntsen, President and CEO of Lupus and Allied Diseases Association.
Mr. Spiegel plays a patient testimonial video from Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association, an ASBM member group.
Dr. Gewanter discusses biosimilar labeling in the U.S., including what information physicians and pharmacists consider important to include.
Andrew Spiegel explains how data and transparency are the key to building patient and physician confidence in biosimilars.
