by Philip Schneider, MS FASHP FFIP Advisory Board Chair, Alliance for Safe Biologic Medicines
This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post.
My comments that were misinterpreted in this article arose from a discussion about the importance of duly considering safety and effectiveness, in addition to cost, when making decisions about the choice of drug therapy. My mention of thalidomide was in reference to a seminal event that made ensuring the safety of drugs and other medical products a priority for the FDA and to show how the FDA has ably fulfilled this mission in the ensuing decades. In no way was I linking biosimilars to the thalidomide experience. The basic underpinning of every presentation I have ever given, comments I have submitted or testimony I have provided is that all biosimilars are to be considered “safe and effective” once approved by the FDA.
By way of background, I was interviewed as chairman of the international advisory board of the Alliance for Safe Biologic Medicines (ASBM). In this capacity, I represent an organization that since 2010 has promoted biosimilars as a strategy to increase access to new breakthrough biologic therapies.
I bring to my role with ASBM more than forty years of experience in academic health sciences centers as both a practitioner and faculty member; I have never been an employee of the pharmaceutical industry. My comments regarding the safety of biosimilars were taken out of context and wrongly portrayed. I have testified on behalf of ASBM in many states in support of legislation that authorizes pharmacists to automatically substitute less expensive interchangeable biosimilars approved by the FDA; legislation that has now been passed in 45 of 50 states in the US.
I have also testified on eight occasions to the World Health Organization in support of their Biologic Qualifier program that assigns distinguishable non-proprietary names to biosimilars to improve confidence in their use among prescribers, pharmacists, and patients to speed uptake. I have conductedmany continuing education programsfor health care professionals promoting the safe use of biosimilars; something quite inconsistent with the impression left in the Washington Post article.
Let me be clear: I support the availability and use of biosimilars. By taking one of my comments out of context, the article misleads readers into believing that I oppose them. I am writing this to correct this irresponsible reporting by the Post.
December 3rd-5th, ASBM exhibited at the Midyear Meeting of the American Society of Health-system Pharmacists (ASHP) in Anaheim, CA. The meeting was attended by more than 25,000 pharmacists and is widely known in the pharmacy community as the largest professional gathering of pharmacists in the world.
ASBM was represented at the Midyear Meeting by its Advisory Board Chair, Philip Schneider, MS, FASHP, FFIP; who is a past president of ASHP.
At ASBM’s booth, Schneider and ASBM staff distributed information to attendees regarding key biosimilar policy issues which affect pharmacy practice. These include biosimilar approval, biosimilar naming, substitution policy at the state level, and the non-medical switching of patients’ biologic medicines by payers.
Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and fellow ASBM Advisory Board member Ron Jordan, Dean of the Chapman University College of Pharmacy and past president of the American Pharmacist Association (APhA).
ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe. Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
ASBM to Meet with Health Canada and FDA to Discuss International Harmonization of Biologic Naming
On January 24th, 2019, ASBM will host the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants will include representatives from Health Canada and the FDA.
The meeting, to be held in Ottawa, Ontario will serve as a follow-up to prior meetings held during April and July in Washington, DC. In addition to the regulators, participants will include members of leading physician and pharmacist societies, and patient advocates from the disease states commonly treated with biologic medicines.
The April 11th meeting was the subject of a recent whitepaper prepared by Scientific American, which co-hosted the meeting.
ASBM Exhibits at the ASHP Midyear Meeting
December 3rd-5th, ASBM exhibited at the Midyear Meeting of the American Society of Health-system Pharmacists (ASHP) in Anaheim, CA. The meeting was attended by more than 25,000 pharmacists and is widely known in the pharmacy community as the largest professional gathering of pharmacists in the world.
ASBM was represented at the Midyear Meeting by its Advisory Board Chair, Philip Schneider, MS, FASHP, FFIP; who is a past president of ASHP.
At ASBM’s booth, Schneider and ASBM staff distributed information to attendees regarding key biosimilar policy issues which affect pharmacy practice. These include biosimilar approval, biosimilar naming, substitution policy at the state level, and the non-medical switching of patients’ biologic medicines by payers.
Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and fellow ASBM Advisory Board member Ron Jordan, Dean of the Chapman University College of Pharmacy and past president of the American Pharmacist Association (APhA). ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.
In mid-November, ASBM released three videos in which pharmacists discussed key biosimilar policy issues. The videos featured ASBM Advisory Board Chair Philip Schneider, MS FASHP; Professor at Ohio State University College of Pharmacy, and past president of the American Society of Health-system Pharmacists. Professor Schneider is joined by Chapman University School of Pharmacy’s Professor Daniel Tomaszewki, PhD, PharmD; a frequent participant in ASBM’s Continuing Education courses for pharmacists.
The first video is entitled “Pharmacists and Biologic Naming” and may be viewed here.
The second video is entitiled “Pharmacists and Biosimilar Subsitution” and may be viewed here.
The third video is entitled “Pharmacists and Non-Medical Switching” and may be viewed here.
FDA Approves 15th Biosimilar, First for Treatment of Non-Hodgkins Lymphoma
On November 28th, the U.S. Food and Drug Administration (FDA) approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.
With the Truxima approval, the FDA has approved 15 biosimiliars.
Read the FDA’s press release about the approval here.
FDA Approves 14th Biosimilar, 2nd for Pegfilgrastim
On Nov. 2, 2018, the FDA approved Udenyca (pegfilgrastim-cbqv) from Coherus, as the second biosimilar to Neulasta (pegfilgrastim). The first, Fulphila (pegfilgrastim-jmdb) was approved by the FDA in June 2018.
Like their reference product, the biosimilars are used to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
Benefits of WHO’s BQ Proposal to Middle East, North Africa
On November 2nd, 2018, GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier”.
The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would bring to Middle Eastern and North African countries if and when it were to be made available. From the abstract:
When it comes to monitoring the quality, safety and efficacy of biological medicines, distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biological medicines. Since no biosimilar is perfectly identical to its innovator parent, every biological – whether reference product or biosimilar – must be fully distinguishable from other biologicals to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming of all biologicals will improve patient safety by reducing confusion and mishaps in prescribing and holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologicals including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.The World Health Organization (WHO) must finalize their Biologic Qualifier guidance. It is this organization that has the responsibility to ensure that developing nations of the world have access to affordable, quality medicines. Safety is mission critical and the Biological Qualifier is a potent tool on behalf of global public health.
The article will also be published in GaBI Journal’s next print edition. Read the full article here.
UPCOMING EVENTS DIA Europe MeetingVienna, Austria – February 5, 2019
APhA Annual Meeting
Seattle, WA – March 22-25, 2019
On November 2nd, 2018, the GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier”.
The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would bring to Middle Eastern countries if and when it were to be made available. From the abstract:
When it comes to monitoring the quality, safety and efficacy of biological medicines, distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biological medicines. Since no biosimilar is perfectly identical to its innovator parent, every biological – whether reference product or biosimilar – must be fully distinguishable from other biologicals to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming of all biologicals will improve patient safety by reducing confusion and mishaps in prescribing and holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologicals including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.The World Health Organization (WHO) must finalize their Biologic Qualifier guidance. It is this organization that has the responsibility to ensure that developing nations of the world have access to affordable, quality medicines. Safety is mission critical and the Biological Qualifier is a potent tool on behalf of global public health.
On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 66th INN Consultation may be viewed here.
The day prior to the INN Consultation, ASBM released a whitepaper on an April 11 meeting on Harmonization of Biologic Nomenclature sponsored by ASBM and Scientific American. That meeting and the resulting whitepaper revealed strong stakeholder support both for distinct naming and for international harmonization of naming systems; participants agreed that WHO involvement was necessary to advance these aims. The meeting included representatives from FDA, Health Canada, physician societies, pharmacists, and patient advocacy organizations. A follow-up meeting was held on July 12th at which support for distinct naming, international harmonization of nomenclature, and WHO leadership were reiterated.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
ASBM Chair Presents at ArthritisPower Patient Governor’s Summit
On October 6th, ASBM Chair Madelaine Feldman, MD, FACR, presented at the 5th annual ArthritisPower Patient Governors’ Summit in Phoenix, AZ. The Summit was presented by the Global Healthy Living Foundation, an ASBM Steering Committee Member.
Dr. Feldman’s presentation provided an overview of biologic medicines and biosimilars, and examined key biosimilar policy issues including naming, substitution, labeling, and non-medical switching. Dr. Feldman shared perspectives on these issues and discussed ASBM’s work in addressing them at the state, federal and international level.
ASBM Presents to European Oncology Nurses at ESMO 2018
On October 19th, ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave a presentation to the European Oncology Nurses Society in Munich, Germany.
The presentation reflected the excitement for biosimilars among the patient community, but emphasized the importance to patients of controlling their treatment decisions. Also important to patients was ensuring clear product identification with distinct naming for all biologics, including biosimilars; this helps ensure accurate attribution of adverse events to the correct product and avoid inappropriate or inadvertent subsitution.
ASBM Exhibits at ACR/ARHP Annual Meeting in Chicago
From October 21st- October 23rd, ASBM exhibited at the 2018 Annual Meeting of the American College of Rheumatology/Association of Rheumatology Healthcare Professionals, held in Chicago, IL. The conference was attended by more than 15,000 rheumatology health professionals from more than 100 countries.
ASBM Chair Madelaine Feldman, MD FACR and ASBM’s Immediate Past Chair Harry Gewanter, MD MACR both spent time at the ASBM booth in the patient pavilion, interacting with their fellow rheumatologists from the US and around the world. At the booth, ASBM distributed its new whitepaper on international harmonization of biologic nomenclature.
Dr. Feldman also led a session on increasing patient access to biologic medications, including the role Pharmacy Benefit Managers (PBMs) play. In her presentation, Dr. Feldman emphasized the importance of therapeutic choice remaining with patients and their clinicians; rather than with third parties such as PMBs, insurers, or government agencies.
ASBM/Scientific American Whitepaper Shows Strong Regulator Support for Distinct Naming, International Harmonization
A whitepaper released October 22nd by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe.
According to the paper, regulators, physicians, and patients are supportive of international harmonization of biologic names and are calling on the WHO to implement the proposed naming system so that it is available for regulators to use.
The paper is based on a roundtable discussion on international harmonization of biologic nomenclature held April 11th in Washington DC. Participants included representatives from the U.S. FDA and Health Canada, major physician and pharmacist societies, and patient advocates. The forum was sponsored by the Alliance for Safe Biologic Medicines (ASBM) and Scientific American, which prepared the paper.
Despite wide support for the BQ proposal outside of WHO as well – regulators support it by a 2-to-1 margin as do large majorities of surveyed physicians in the US (66%) and Canada (68%) Australia (79%) and in Latin America (94%) – WHO has not yet implemented the system its expert committee recommended.
On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013. Gail Attara, President and CEO of the Canada-based Gastrointestinal Society, an ASBM member, also presented.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 66th INN Consultation may be viewed here.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
ASBM Exhibits at DIA Annual Canadian Meeting
October 30th-31st, ASBM exhibited at the 2018 DIA Annual Canadian Meeting, held in Ottawa, ON. ASBM was represented by Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association.
Mr. Spiegel staffed ASBM’s booth, and spoke with attendees about ASBM’s work on the international harmonization of biologic nomenclature, including meetings with Health Canada, FDA, and WHO in Washington, DC during April and July.
Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now
A whitepaper released today by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe. Names – of products, people, places – are important in many settings but perhaps nowhere more important than in the medical arena where confusion could be dangerous. Harmonization of naming practices for biologic medicines is seen as essential for maintaining a safe supply of biologic medicines. Regulators and physicians believe WHO is best positioned to lead this effort.
Biologic medicines have revolutionized the treatment of many chronic illnesses and less expensive versions of these important medicines are becoming available. However, because biologics are made using living cells, no two products from different manufacturers will be the same. Distinguishable names for biologics made by different manufacturers enable doctors to prescribe, pharmacists to dispense and regulators to track biologics with specificity.
According to the newly released paper, regulators, physicians, and patients are supportive of international harmonization of biologic names and are calling on the WHO to implement the proposed naming system so that it is available for regulators to use.
The paper is based on a roundtable discussion on international harmonization of biologic nomenclature held April 11th in Washington DC. Participants included representatives from the U.S. FDA and Health Canada, major physician and pharmacist societies, and patient advocates. The forum was sponsored by the Alliance for Safe Biologic Medicines (ASBM) and Scientific American, which prepared the paper.
The World Health Organization has examined biologic naming extensively. In 2014, the WHO’s Expert Group responsible for medicine naming recommended the WHO implement a voluntary international standard of naming for all biologics using a “biologic qualifier” or BQ. The BQ is a four-letter suffix that would be appended to the root scientific name – the International Nonproprietary Name (INN) – assigned by WHO. Biologic medicines with a certain level of similarity would have the same INN so the BQ would distinguish each biologic by a different manufacturer, thus enabling regulators to attribute any problems to the exact product. This is important due to the very sensitive nature of biologics and the risk of an unwanted immune response by patients.
Despite wide support for the BQ proposal outside of WHO as well – regulators support it by a 2-to-1 margin as do large majorities of surveyed physicians in the US (66%) and Canada (68%) Australia (79%) and in Latin America (94%) – WHO has not yet implemented the system its expert committee recommended.
In the absence of action by WHO, regulators around the world have begun to act independently. The FDA implemented its own BQ-like naming system in 2015, and Japan has adopted a different distinct suffix system. Canada is looking for global harmonization but considering a regional approach as an alternative. If not reconciled soon, the divergent naming practices could make prescribing, dispensing and tracking difficult in a global economy and impede access to these life-saving medicines.
“A regulator’s job is not confined to the corners of their geography,” says Anthony Ridgway, acting director of the Centre for Evaluation of Radiopharmaceutical and Biotherapeutics at Health Canada, who participated in the forum. Continued lack of clarity globally makes identification and association of adverse reactions across jurisdictions, and resolution of problems, more difficult. A harmonized international naming standard would help patients who fill prescriptions while travelling internationally, for example.
The BQ’s benefits might be felt most by lower- and middle- income countries without their own robust pharmacovigilance systems. “The WHO is indispensable in building a global system of pharmacovigilance for biologics,” says Michael Reilly, ASBM’s executive director.
ASBM released the paper simultaneously at the WHO’s 67th International Consultation on Nonproprietary Names, in Geneva, Switzerland; and at the 2018 Annual Meeting of the American College of Rheumatology in Chicago, IL. The paper is also available here.
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Three physicians and two patient advocates discuss their concerns with the non-medical switching of biologic medicines by third parties such as insurers or pharmacy-benefit managers (PBMs).
ASBM’s Chair, Madelaine Feldman, MD FACR is joined by ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; and ASBM’s Founding Chair, Richard Dolinar, MD; to discuss physician perspectives on NMS. The patient perspective is provided by two ASBM Steering Committee Members: Andrew Spiegel of the Global Colon Cancer Association (GCCA); and Kathleen Arntsen of Lupus and Allied Diseases Association (LADA).
Three physicians and two patient advocates discuss their concerns with the non-medical switching of biologic medicines by third parties such as insurers or pharmacy-benefit managers (PBMs).
ASBM’s Chair, Madelaine Feldman, MD FACR is joined by ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; and ASBM’s Founding Chair, Richard Dolinar, MD; to discuss physician perspectives on NMS. The patient perspective is provided by two ASBM Steering Committee Members: Andrew Spiegel of the Global Colon Cancer Association (GCCA); and Kathleen Arntsen of Lupus and Allied Diseases Association (LADA).
On September 30th, ASBM presented a 5-hr Continuing Education (CE) course for more than 75 New York area pharmacists. The majority of these attendees were drawn from community pharmacy practice, with a smaller number practicing in health system pharmacy.
ASBM’s expert panel, from left to right: ASBM Advisory Board Chair Philip Schneider, MS FASHP FFIP; ASBM Chair Madelaine Feldman, MD FACR; ICAN’s Scott Kahn, PhD; PAREXEL’s Partha Roy, PhD; and Chapman University’s Daniel Tomaszewski, PharmD, PhD.
The CE course was presented in conjunction with The Arnold and Marie Schwartz College of Pharmacy at Long Island University (LIU-Pharmacy) This was the third time ASBM has presented a version of this course with LIU-Pharmacy, the first being in 2015 as the first US biosimilar was being approved, the second in 2016, by which time four biosimilars had been approved.
The course began with introductory remarks by Joseph R. Bova, M.S., R.PhI,Director of Continuing Professional Education for LIU-Pharmacy. Mr. Bova then administered pre-course learning assessment questions, which were designed to gauge the audience’s pre-existing knowledge of an familiarity with biologics and biosimilars. For example, one question asked how many biosimilars were currently approved in the US- none, four, twelve, or thirty. (Today 12 biosimilars are approved, though only 4 are currently being marketed.) Another question asked whether biosimilars were inherently interchangeable with their reference product; they are not and must be approved as interchangeable by FDA.
Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
In the first presentation, Dr. Schneider begins by explaining what biologic medicines are, how they were developed and approved, and how they are used to treat serious conditions including rheumatoid arthritis and cancer. He then explains safety, storage and handling considerations that result from the greater size, complexity, and sensitivity of biologics, relative to small molecule drugs. He follows with a discussion of biosimilars, discussing differences between biosimilars and chemical generics- chief among them that biosimilars are not identical but only similar to their reference products.
Schneider then examines the need for clear product identification with biologic medicines, including biosimilars, and shares perspectives from regulators, national pharmacist organizations, and surveys of pharmacists regarding possible naming conventions for biosimilars.
Physician Perspectives on Biosimilars Madelaine Feldman, MD, FACR Chair, Alliance for Safe Biologic Medicines
In this presentation, Dr. Feldman discusses physician perspectives on four key policy biosimilar policy issues affecting medical and pharmacy practice: Naming, Interchangeability and Substitution, Non-Medical Switching, and Increasing Biosimilar Uptake.
Dr. Feldman began with a discussion of ASBM, its surveys and its work bringing the patient, physician and pharmacist perspectives to regulators worldwide. This includes ASBM’s history of participations in the WHO INN Consultations and its recent discussion forums on biosimilar naming in which the WHO, FDA, and Health Canada participated.
Regarding naming, Dr. Feldman discussed the importance to physicians worldwide of distinct naming for all biosimilars. Support varies from 66% to 94% depending on country and region. She noted that significant percentages of physicians globally use the nonproprietary name when recording the prescribed biologic medicine in the patient record, which could result in the patient receiving the wrong medicine. Similarly, significant percentages of physicians worldwide use only the nonproprietary name when recording adverse events; which could result in misattribution.
Regarding substitution, Dr. Feldman emphasized the importance to physicians of communication from the pharmacist in the event of a biosimilar subsitution; and of retaining the authority to prevent a substitution they deem medically inappropriate by using “dispense as written” (DAW). She also clarified that the U.S.-specific standard of “interchangeability”-applied to biosimilars suitable for pharmacy-level substitution- is not intended to be transitive. That is to say, even if biosimilar A and biosimilar B are both interchangeable with the same reference product, they are not interchangeable with each other. Dr. Feldman discussed physician concerns with the non-medical switching of patients on biologics- switching these patients’ medicine for non-medical reasons. This is typically done by an insurer or PBM for cost or other financial reasons. Treatment decisions, including which biologic to use and if and when to switch, should be made by the patient in consultation with his or her healthcare team, rather than a third party payer.
Finally, Dr. Feldman discussed ways to increase biosimilar uptake- including the physician’s cautious approach to choosing a medicine. Data showing safe use and safe switching of stable patients, she noted, are critical to building physician confidence. Distinct naming also reassures physicians that these products can be used safely and their effects tracked accurately. Yet many of the obstacles to biosimilar uptake are commercial, and more approvals and lower cost does not translate to greater access for patients. For example, while 12 biosimilars are approved, only 4 are currently available. Also, manufacturer rebate arrangements mean that PBMs may not give the lowest cost product preferred placement, posing a further barrier to uptake.
Biologic and Biosimilar Naming: Pharmacist Perspectives and International Harmonization Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
In this presentation, Dr. Schneider discussed considerations in the naming of biologics, including biosimilars, and the benefits of distinct naming. He discussed naming systems in use around the world, including the FDA’s four-letter suffix system, and the WHO’s proposed biologic qualifier or “BQ” system, which would also use a four-letter suffix if implemented. He explained the various positions of national pharmacy organizations on naming, and shares survey data from ASBM and the Academy of Managed Care Pharmacy showing strong support among US pharmacists for distinct naming.
He also discusses the benefits of and progress toward international harmonization of biologic nomenclature, including ASBM’s work with the WHO’s INN Programme. He highlighted perspectives gathered at ASBM’s April and July 2018 forums at which FDA , Health Canada, WHO, and other stakeholders met to discuss the need for harmonization. Finally, Dr. Schneider discussed his work with the International Pharmaceutical Federation (FIP) which has begun addressing the issue of distinct biologic naming in its policy guidelines and its educational sessions.
Biosimilars: The Patient Advocate’s Perspective Scott Kahn, PhD Biomarkers Council Chair, International Cancer Advocacy Network (ICAN)
In this presentation, Dr. Scott Kahn presented the patient advocate’s perspective on biosimilars. The patient advocacy community, Dr. Kahn explainsed, is very excited about the promise of biosimilars. He emphasized the value that biologics have brought to patients in terms of increasing lifespan and quality of life. Biosimilars, Kahn explained, will increase access to biologic therapies, offer new therapeutic choices to patients, and lower healthcare costs.
But, he cautioned, patients have certain expectations of their policymakers and health care providers. For example, they expect that biosimilars are held to the same standards of purity, safety, and efficacy as their reference products. Also, they expect that the health and safety of the patient, rather than any potential cost savings, remains the focal point of any biosimilar policy. Finally, they expect to retain, with their healthcare team, control over treatment decisions. Dr. Kahn emphasized that patients have strong reservations about the prospect of Non-Medical Switching-by third parties such as a private insurer, PBM, or government agency-which could cause stable patients to lose control over their disease. Finally, Dr. Kahn turned to the importance of the pharmacist-patient relationship, calling pharmacists “the last line of defense” in a chain of patient safety that begins with the researcher and continues through the manufacturer and the regulator, and ultimately ends with the patient.
Biosimilars: Regulatory & Drug Development Partha Roy, PhD Principal Consultant, PAREXEL Consulting
In this presentation, Dr. Roy laid out in great depth the biosimilar evaluation and approval process. This includes such considerations such as analytic and clinical evaluation, interchangeability, and indication extrapolation. Dr. Roy also discussed the current regulatory environment surrounding biosimilar approvals, including a regulatory history of the U.S. biosimilars pathway, which has its origins in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which laid the framework for U.S. biosimilar development.
He discussed the definition of biosimilarity set by the BPCIA, and outlines how the totality of clinical and non-clinical evidence is used by the FDA to determine biosimilarity. He then examined in detail how biosimilars are evaluated, including trial design, biosimilar trial recruitment challenges, PK and PD studies, factors that impact immunogenicity, and clinical considerations. Dr. Roy’s presentation concluded with discussion of concerns regarding the so called “transtition” products- biologic products that in 2020 will transition from being follow-on biologics approved under the (505) pathway to the (351) pathway, either as stand-alone biologics or as biosimilars.
Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
The next presentation was given by Dr. Schneider, and dealt with biosimilar substitution policy in the United States. Dr. Schneider emphasized that while Congress sets the legal definition of interchangeability, and the FDA makes the scientific determination of which biosimilars are interchangeable, it is the individual States that govern when and how a pharmacist can substitute an interchangeable biosimilar.
Following a brief discussion about substitution policy globally (including Canada, the EU, Latin America, and Australia) Dr. Schneider spoke about the evolution of biosimilar substitution legislation in the US.
He focused his discussion on laws passed by 45 states and Puerto Rico which require a pharmacist to communicate to the prescribing physician which product- the originator or the biosimilar- was actually dispensed to the patient. These states also allow a physician to specify “do not substitute” or “dispense as written” in order to prevent a substitution they consider medically inappropriate.
A collaborative and communicative approach to pharmacovigilance, Schneider argued, is good for everyone. It empowers the pharmacist to offer the patient new and lower-cost treatment options, it allows the patient to be an engaged partner in a their own care, it allows the physician to maintain an accurate patient record and make informed treatment decisions, and it improves safety overall by promoting accurate attribution of adverse events to the proper medicine.
Pharmacists and Biosimilars: Impact of Naming Conventions and Notification on Substitution Daniel Tomaszewski, RPh, Phd Assistant Professor in Pharmacy Administration, Chapman University
In this presentation, Dr. Tomaszewski discusses the role of pharmacists in collaboratively managing patient care regarding biologics. This includes managing prior authorizations from PBMs, and dealing with patient use concerns including ensuring adherence and increasing familiarity with biosimilars. He discussed his work with AMCP on a 2016 study that showed strong support for distinct names for biosimilars. He emphasized the importance of real world evidence (RWE) in building confidence in biosimilars, and the importance of pharmacists in gathering it. Echoing the concerns of many physicians, Dr. Tomaszewski discussed the impact of post-approval barriers to biosimilar access including patent litigation and payer policies. He concluded with proposals on how to improve education on biosimilars, including
Dr. Tomaszewski answers a question from the audience during Q and A.
Following the presentations, the speakers answered questions in the audience. The program concluded with Post-Course Learning Assessment questions, again administered by Joseph R. Bova, M.S., R.PhI,Director of Continuing Professional Education for LIU-Pharmacy. Responses showed improvement in the knowledge of biosimilars, with nearly all attendees correctly answering the questions posed previously, demonstrating increased familiarity with biosimilars.
“Biosimilars are structurally identical to their reference product”. Before the course, the audience responses were evenly divided between “True” and “False”.. Afterward, 71% answered correctly that the statement was false.
In this presentation, Dr. Roy laid out in great depth the biosimilar evaluation and approval process. This includes such considerations such as analytic and clinical evaluation, interchangeability, and indication extrapolation. Dr. Roy also discussed the current regulatory environment surrounding biosimilar approvals, including a regulatory history of the U.S. biosimilars pathway, which has its origins in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which laid the framework for U.S. biosimilar development.
