March 2017 Newsletter
March 5, 2017
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ASBM Shares International Perspectives, Australian Physician Insights with Australian Policymakers, Patient and Physician Groups
March 2, 2017
ASBM held a series of meetings in February with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.
The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia.
Australia has been a leader in recognizing the need for distinct naming of biosimilars, and its adoption of a distinct naming system was influential in the development of the World Health Organization’s Biological Qualifier (BQ) proposal, which would extend the protections of distinct biologic naming to patients globally. The Australian survey revealed that 76% of Australian prescribers support the TGA issuing distinct names for all biologics, including biosimilars.
In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.
Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.
The full survey results may be read here.
Meetings included:
Members of Parliament:
Office of Minister Catherine King, Shadow Minister for Health and Medicare
Dr. David Gillespie MP – Assistant Minister for Health
Office of Minister Greg Hunt – Minster for Health
Government:
Therapeutic Goods Administration (TGA)
Australian Department of Health
Patient Groups:
Arthritis Australia
Consumer Health Forum
Crohn’s and Colitis Australia
Physician Groups:
Australian Rheumatology Association
Australian Diabetes Society
Gastroenterology Society of Australia
Pharmacy:
Pharmacy Guild of Australia
Other Stakeholders:
Medicines Australia
NPS Medicinewise
ASBM’s Schneider testifies in support of NM Substitution Bills
February 21, 2017
On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support and the Senate Corporations and Transportation Committee to support HB 260 and SB 180; both bills contain identical language.
From Dr. Schneider’s testimony:
“Current New Mexico law has no clear pathway for substitution of biosimilar drug products. [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 26 states have passed similar legislation in the past few years”.
Both bills subsequently passed unanimously out of their respective committees.
New research reveals how Australian physician confidence in prescribing biosimilars could be bolstered
February 16, 2017
A leading authority on international biosimilar medicines policies today released new research that identifies key areas to improve Australian physicians’ confidence in prescribing biosimilar medicines.
The Alliance for Safe Biologic Medicines (ASBM), a non-profit organization, surveyed 160 Australian physicians who prescribe biologics from seven therapeutic specialties with respect to their beliefs and attitudes toward biosimilar medicines. The survey, which is the largest of its kind with Australian physicians, is similar to those undertaken by the Alliance with physicians in the US, Europe, Canada and Latin America in recent years.
“Australian specialists have clear preferences when it comes to naming, adverse event reporting and substitution practices for biosimilar medicines, and these echo similar sentiment being expressed by physicians internationally,” said Michael Reilly, Executive Director, ASBM.
The research findings are to be published in an article authored by Mr.. Reilly in a forthcoming issue of the Generics and Biosimilar Initiative Journal, in which he compares the Australian specialists’ views with their peers in Canada and Europe.
Naming and adverse event reporting
The Australian survey highlights physicians’ overwhelming desire for every biosimilar and originator biologic to have a distinct nonproprietary scientific name. Three quarters (76%) believe the Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products.
Similar responses were seen in the ASBM research conducted amongst physicians in Canada and Europe. For example nearly 8 out of 10 Canadian physicians said their Government should make distinct nonproprietary names mandatory, as did more than 70% (72%) of European physicians.
“The discussion around naming, which is ongoing worldwide, is important as the majority of Australian physicians’ said that if two biologic medicines have the same name, they would infer that the medicines are identical, are able to be switched, and are approved for all the same indications,” said Mr. Reilly. “As we know, this is not accurate for biologics, which are not identical and appropriateness of substitution is determined on a case by case basis. The misunderstanding that is fostered by shared names raises potential safety concerns and presents difficulties with identifying the correct source of adverse events.”
Pharmacy substitution
Nine out of 10 Australian physicians said it was critical or very important that the prescriber and patient have the ultimate decision on which biologic is dispensed. A further 9 out of 10 (89%) believe it is critical or very important that they be notified in the event of a pharmacy-level substitution.
“Australian physicians were almost unanimous in believing they should be notified in the event of a pharmacy level substitution. At present this is not a systematic requirement under the current dispensing regimen for biosimilars in Australia,” said Mr. Reilly.
Physicians in Canada, Europe and Latin America provided similar responses. For example, nearly 9 out of 10 Canadian physicians said it was critical or very important for prescribers to decide which biologic is most suitable for their patients, and 85% said it was critical or very important for physicians to be notified when their patient’s medication has been switched. In Europe more than three quarters (77%) said it was crucial or very important to be notified of a switch.
“Our findings appear to complement and expand upon research by the Australian Government’s Biosimilar Awareness Initiative to inform their communications activities,” Mr. Reilly said. “We look forward to exploring these insights further with local health professional groups, consumer organisations and Government organisations with an interest in this area, to help increase physician confidence and encourage the appropriate use of biosimilars in Australia.”
Mr. Reilly will be in Australia from February 13th to 17th to meet with interested parties to share the findings of the ASBM research into Australian specialists’ perspectives in relation to biosimilars.
About the ASBM
The Alliance for Safe Biologic Medicines has representation from a diverse range of healthcare groups and individuals —patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
The Alliance regularly attends and presents at health conferences and meets with key stakeholders in relation to biosimilar policy. ASBM is involved in the consultation process for the World Health Organization’s development of the International Nonproprietary Name (INN) Programme’s Biologic Qualifier (BQ) proposal.
About the survey
The Australian Prescribers and Biosimilars survey involved 160 Australian physicians who prescribe biologics from seven therapeutic specialties – dermatology, endocrinology, gastrointestinal, nephrology, neurology, oncology, and rheumatology – who have been in practice for at least a year and prescribe biologic medicines in their practice
The activities of the Alliance are funded by its member partners who are all asked to contribute. More details can be found here: https://safebiologics.org/member-partners/
Industry Standard Research, LLC, conducted the research on behalf of the ASBM.
For media inquiries, please contact:
Sue Cook Nicki Sambuco
SenateSHJ SenateSHJ
0456 977 729 0452 446 084
February 2017 Newsletter
February 7, 2017
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ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill
January 26, 2017
On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day. Read ASBM’s letter of support for HB 2107 here.
Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients including lower costs, while highlighting the importance to patients of transparency and knowing what product they receive.
ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally, so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here.
Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part:
“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient. Pharmacists will have up to 5 business days to relay information on which medication is dispensed, so that all providers will have an accurate patient medical record…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”
Read Dr. Schneider’s written testimony in support of HB 2107 here.
ASBM Briefs Kansas Legislators; Testifies in Support of Substitution Bill
January 26, 2017
On January 24th, ASBM participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107, a recently introduced biosimilar substitution bill similar to those passed by 26 states and Puerto Rico. ASBM had submitted a letter of support for the bill the previous day. Read ASBM’s letter of support for HB 2107 here.
Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients including lower costs, while highlighting the importance to patients of transparency and knowing what product they receive.
ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally, so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here.
Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part:
“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient. Pharmacists will have up to 5 business days to relay information on which medication is dispensed, so that all providers will have an accurate patient medical record…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”
Read Dr. Schneider’s written testimony in support of HB 2107 here.
ASBM Statement on FDA’s Final Naming Guidance
January 13, 2017
FOR IMMEDIATE RELEASE
ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products
(Issued January 12, 2017)
ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:
We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs.
Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be ‘devoid of meaning’.
Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.
Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.
It remains ASBM’s position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.
Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.
The physicians surveyed support the FDA’s issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).
Similarly, the survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.
About ASBM
Formed in 2010, ASBM is an organization of patients, physicians, pharmacists, researchers, manufacturers of both innovative and biosimilar medicines, and others who are working together to ensure patient safety remains at the forefront of the biosimilars policy discussion.
For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
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ASBM Steering Committee Members:
Alliance for Patient Access
American Academy of Dermatology
American Autoimmune Related Diseases Association (AARDA)
Association of Clinical Research Organizations
Colon Cancer Alliance
Global Colon Cancer Association
Global Healthy Living Foundation
Health HIV
Hepatitis Foundation International
International Cancer Advocacy Network
Kidney Cancer Association
National Psoriasis Foundation
ZeroCancer
ASBM Statement on FDA’s Final Naming Guidance
January 13, 2017
FOR IMMEDIATE RELEASE
ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products
(Issued January 12, 2017)
ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:
We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs.
Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be ‘devoid of meaning’.
Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.
Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.
It remains ASBM’s position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.
Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.
The physicians surveyed support the FDA’s issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).
Similarly, the survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.
About ASBM
Formed in 2010, ASBM is an organization of patients, physicians, pharmacists, researchers, manufacturers of both innovative and biosimilar medicines, and others who are working together to ensure patient safety remains at the forefront of the biosimilars policy discussion.
For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
###
ASBM Steering Committee Members:
Alliance for Patient Access
American Academy of Dermatology
American Autoimmune Related Diseases Association (AARDA)
Association of Clinical Research Organizations
Colon Cancer Alliance
Global Colon Cancer Association
Global Healthy Living Foundation
Health HIV
Hepatitis Foundation International
International Cancer Advocacy Network
Kidney Cancer Association
National Psoriasis Foundation
ZeroCancer
January 2017 Newsletter
January 7, 2017
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