November-December 2018 Newsletter
December 1, 2018
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Search Results for "harmonization"
ASBM Presents at 67th WHO INN Consultation
November 6, 2018
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.
October 2018 Newsletter
November 1, 2018
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Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now
October 22, 2018
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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ASBM Presents 5-Hour CE Course to NY Pharmacists
October 1, 2018
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.
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.
View Dr. Schneider’s presentation here.
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.
View Dr. Feldman’s presentation here.
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.
View Dr. Schneider’s presentation here.
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.
View Dr. Kahn’s presentation here.
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.
View Dr. Roy’s presentation here.
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.
View Dr. Schneider’s presentation here.
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
View Dr. Tomaszewski’s presentation here.
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.
ASBM Chairs Past and Present, Four Steering Committee Members Testify at FDA Biosimilar Hearing
September 13, 2018
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition:
- Improving the efficiency of the biosimilar and interchangeable product development and approval process
- Maximizing scientific and regulatory clarity for the biosimilar product development community
- Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
- Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products
All Three of ASBM’s Chairmen Presented
ASBM’s current Chair, Madelaine Feldman, MD FACR gave an eight-minute presentation followed by a three-minute Q&A period during which she answered questions from the FDA panel.
Dr. Feldman’s comments featured prominently in in this Bloomberg news coverage of the hearing:
“Theoretically, by putting [biosimilars] on drug formularies, PBMs rake in lower profits because reimbursements for biosimilars aren’t as high as reimbursements for the original biologic, PBM critics say. That lack of formulary access for biosimilars is called the “formulary wall” and is one of the biggest factors keeping biosimilars from reaching patients, according to drugmakers, patient groups, and biosimilar advocates.”
“The barriers to access are not scientific but commercial,” Madelaine Feldman, the chair of the Alliance for Safe Biologic Medicines, said at a public hearing at the FDA’s headquarters Sept. 4. The group is made up of doctors’ associations and patient groups.
ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; (ASBM Chair 2014-2017) and ASBM’s founding Chairman, endocrinologist Richard Dolinar, MD (ASBM Chair 2011-2014) also gave eight-minute presentations sharing their clinical perspectives, followed by a three-minute Q&A portion.
Key themes of the physician presentations included:
- Praise for the FDA’s strong, science-based standards and concern that the lowering of these standards could undermine confidence
- An emphasis on barriers to biosimilar uptake being largely post-approval (PBM rebates, litigation)
- The need for physicians and patients to control treatment decisions rather than a third-party such as an insurer or PBM
- How the gathering of real world evidence on biosimilar use, particularly among patients who switch, can build physician confidence
- The importance of distinct biologic/biosimilar naming to pharmacovigilance and of working toward international harmonization with WHO and other regulators
- Urging FDA to provide further clarification on follow-on biologics approved under the 505(b)(2) that are due to transition in 2020 to the 351 (a) stand-alone biologic or 351(k) biosimilar pathway.
Four ASBM Steering Committee Members Presented
Four ASBM Steering Committee Members also gave eight-minute presentations: Andrew Spiegel, Executive Director of the Global Colon Cancer Association; Kathleen Arntsen of Lupus and Allied Diseases Association, Randall Rutta of the American Autoimmune Related Disorders Association, and Sarah Aoanan of the Global Healthy Living Foundation.
Key themes of the patient presentations included:
- The importance of FDA not sacrificing quality, safety, or efficacy standards in biosimilar approvals
- Excitement among the patient advocate community about biosimilars offering new treatment choices and reduced costs
- The expectation that biosimilar policies must be science-based and patient-focused
- The importance of leaving treatment decisions, including the decision to switch medicines, to the patient and his or her healthcare team
Finally, two ASBM members offered three-minute testimony during the Open Public Hearing portion: Thair Phillips of RetireSafe, and Dr. David Charles from Alliance for Patient Access (AfPA).
View Dr. Feldman’s presentation here.
View Dr. Gewanter’s presentation here.
View Dr. Dolinar’s presentation here.
View Mr. Spiegel’s presentation here.
ASBM Chairs Past and Present, Four Steering Committee Members Testify at FDA Biosimilar Hearing
September 13, 2018
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition:
- Improving the efficiency of the biosimilar and interchangeable product development and approval process
- Maximizing scientific and regulatory clarity for the biosimilar product development community
- Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
- Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products
All Three of ASBM’s Chairmen Presented
ASBM’s current Chair, Madelaine Feldman, MD FACR gave an eight-minute presentation followed by a three-minute Q&A period during which she answered questions from the FDA panel.
Dr. Feldman’s comments featured prominently in in this Bloomberg news coverage of the hearing:
“Theoretically, by putting [biosimilars] on drug formularies, PBMs rake in lower profits because reimbursements for biosimilars aren’t as high as reimbursements for the original biologic, PBM critics say. That lack of formulary access for biosimilars is called the “formulary wall” and is one of the biggest factors keeping biosimilars from reaching patients, according to drugmakers, patient groups, and biosimilar advocates.”
“The barriers to access are not scientific but commercial,” Madelaine Feldman, the chair of the Alliance for Safe Biologic Medicines, said at a public hearing at the FDA’s headquarters Sept. 4. The group is made up of doctors’ associations and patient groups.
ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; (ASBM Chair 2014-2017) and ASBM’s founding Chairman, endocrinologist Richard Dolinar, MD (ASBM Chair 2011-2014) also gave eight-minute presentations sharing their clinical perspectives, followed by a three-minute Q&A portion.
Key themes of the physician presentations included:
- Praise for the FDA’s strong, science-based standards and concern that the lowering of these standards could undermine confidence
- An emphasis on barriers to biosimilar uptake being largely post-approval (PBM rebates, litigation)
- The need for physicians and patients to control treatment decisions rather than a third-party such as an insurer or PBM
- How the gathering of real world evidence on biosimilar use, particularly among patients who switch, can build physician confidence
- The importance of distinct biologic/biosimilar naming to pharmacovigilance and of working toward international harmonization with WHO and other regulators
- Urging FDA to provide further clarification on follow-on biologics approved under the 505(b)(2) that are due to transition in 2020 to the 351 (a) stand-alone biologic or 351(k) biosimilar pathway.
Four ASBM Steering Committee Members Presented
Four ASBM Steering Committee Members also gave eight-minute presentations: Andrew Spiegel, Executive Director of the Global Colon Cancer Association; Kathleen Arntsen of Lupus and Allied Diseases Association, Randall Rutta of the American Autoimmune Related Disorders Association, and Sarah Aoanan of the Global Healthy Living Foundation.
Key themes of the patient presentations included:
- The importance of FDA not sacrificing quality, safety, or efficacy standards in biosimilar approvals
- Excitement among the patient advocate community about biosimilars offering new treatment choices and reduced costs
- The expectation that biosimilar policies must be science-based and patient-focused
- The importance of leaving treatment decisions, including the decision to switch medicines, to the patient and his or her healthcare team
Finally, two ASBM members offered three-minute testimony during the Open Public Hearing portion: Thair Phillips of RetireSafe, and Dr. David Charles from Alliance for Patient Access (AfPA).
View Dr. Feldman’s presentation here.
View Dr. Gewanter’s presentation here.
View Dr. Dolinar’s presentation here.
View Mr. Spiegel’s presentation here.
ASBM Presents to Malta Pharmaceutical Association
July 24, 2018
On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names. It also focused on the need for Real World Evidence (RWE) and improved pharmacovigilance in a world where biosimilars are approved with an emphasis on analytics rather than clinical trials.
Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing these needs. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC, his April 30th meeting with WHO in Geneva, and ASBM’s July 12th Forum in Washington, DC. emphasizing the importance of the WHO assuming a leadership role on this issue:
“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”
View Dr. Schneider’s presentation here.
ASBM Presents to Malta Pharmaceutical Association
July 24, 2018
On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names. It also focused on the need for Real World Evidence (RWE) and improved pharmacovigilance in a world where biosimilars are approved with an emphasis on analytics rather than clinical trials.
Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing these needs. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC, his April 30th meeting with WHO in Geneva, and ASBM’s July 12th Forum in Washington, DC. emphasizing the importance of the WHO assuming a leadership role on this issue:
“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”
View Dr. Schneider’s presentation here.
ASBM Hosts Naming Roundtable With WHO, FDA, Health Canada
July 13, 2018
On July 12, in Washington, DC the Alliance for Safe Biologic Medicines (ASBM) hosted the second in a series of meetings to discuss the global harmonization of nomenclature for biologic and biosimilar medicines.
Representatives from the World Health Organization, the U.S. Food and Drug Administration (FDA), Health Canada, the United States Pharmacopeia (USP), and the American Pharmacists Association (APhA) convened with physician and patient advocacy organizations to discuss the importance of national regulatory authorities (NRAs) working together to develop a nomenclature policy that will improve pharmacovigilance on a global scale.
ASBM International Advisory Board Chair and moderator, Phil Schneider, ASBM Executive Director, Michael Reilly, ASBM President, Doug Badger, and manager of the WHO International Nonproprietary Name (INN) Programme, Dr. Raffella Balocco, WHO
Biologics and biosimilars have greatly expanded treatment options for physicians and patients; yet because of their large molecule structure and manufacturing process which uses living cells, no two biologics are exactly alike. While regulators in some countries have begun to address the naming of these medicines within their own borders, a global harmonization of biologic naming has not yet been achieved. This situation may impede patient safety, prescriber clarity and the uptake of biosimilars as they become more available. It is also more important to less developed countries which may have different standards for approving, tracing and naming medicines.
ASBM believes distinguishable names and a harmonization of naming conventions across regions for all biologics (innovator and biosimilar) would ultimately improve patient safety and access. At the April 11th meeting, hosted by Scientific American and held in DC, there was also agreement at the table that a harmonized naming system was desirable, not just for biosimilars but for all biologics.
“With the growth of this category of medicines, now is the time to address the policy issues in order to maintain strong pharmacovigilance of these products worldwide,” stated ASBM Executive Director, Michael Reilly, “This is why we are convening these meetings for stakeholders to come to the table and discuss moving towards one naming guidance.”
A recap of the April 11th meeting can be found here.
Photos from the April 11th roundtable can be found here.
