May 2019 Newsletter
June 1, 2019
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Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products
May 14, 2019
Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products
May 13, 2019
Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.
Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School. Alliance for Safe Biologic Medicines (ASBM) was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”. Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology, nephrology, and ophthalmology. The full survey may be viewed here.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
“US physicians have once again spoken very clearly in support of the FDA and of distinct naming”, said Madelaine Feldman, MD FACR, Chairwoman of ASBM, who conducted the survey.
A minority of parties submitting comments to the FDA during the recent comment period opposed the FDA policy, including health insurance companies, national chain drug stores, and pharmacy benefit managers. Opponents of distinct naming submitted 17 individual comment letters and a joint comment letter with 29 signatories, compared to more than 250 organizations and individuals who wrote in directly or signed letters of support. Still other commenters supported distinct naming, but had comments on the suffix design or implementation. Biologic manufacturers varied widely in their support.
“Biosimilars offer patients increased access to life-changing therapies, at reduced cost for patients and our health system. In order to reap these benefits, physicians and patients need confidence that adverse events will be attributed to the correct product, be it originator or biosimilar. Physicians and patients have spoken clearly to FDA: distinct naming is essential to building that confidence”, said Dr. Feldman.
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About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups including physicians, patients, pharmacists, manufacturers of innovator biologics and biosimilars, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
Media contact: Ray Patnaude media@safebiologics.org
April 2019 Newsletter
May 1, 2019
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April 2019 Newsletter
May 1, 2019
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ASBM Presents at 68th WHO INN Naming Consultation
April 2, 2019
On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth 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 67th 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.
In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here.
March 2019 Newsletter
April 1, 2019
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ASBM Exhibits at APhA Annual Meeting
March 26, 2019
From March 22nd-24th, ASBM exhibited at the Annual Meeting and Expo of the American Pharmacists Association (APhA), held in Seattle, Washington.Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members.
ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the American Society of Healthsystem Pharmacists (ASHP) and Advisory Board Member Ronald Jordan, Dean of the Chapman University College of Pharmacy and past president of APhA.
Dr. Schneider answered questions about biosimilar policy issues which affect pharmacy practice, including naming practices in the US and internationally. US biosimilar substitution policy, which varies by state, was also discussed.
Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and Jordan, and ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.
ASBM Statement Supporting Updated FDA Naming Guidance
March 12, 2019
ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is important for a patient’s care or to report adverse events.
We understand FDA’s thoughtful solution to the difficult conundrum of products approved prior to adoption of the suffix policy. FDA will not change the nonproprietary names of already approved products in order to avoid confusion that could result. For these long-standing products, the brand name will be the distinguishing element and require more vigilance and effort by prescribers. This exception to the suffix protocol will ultimately play a role in the traceability of a limited number of biologics given that most products will not have biosimilars due to the challenges of biosimilar development.
ASBM Meets with Health Canada, FDA, WHO on Biologic Nomenclature Harmonization
March 7, 2019
On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated.
The meeting began with opening remarks by ASBM Executive Director Michael Reilly thanking the participants. He emphasized the shared support for global harmonization and for WHO leadership in that effort. Participants then introduced themselves; they included:
- Michael Reilly, Executive Director, ASBM
- Philip Schneider, MS FASHP FFIP; Advisory Board Chair, ASBM
- Madelaine Feldman, MD, FACR; Chair, ASBM
- Rafaella Balocco Mattavelli, INN Programme Lead, World Health Organization
- Anthony Ridgway, Health Canada
- Stephanie Hardy, Health Canada
- Andrew Spiegel, Global Colon Cancer Association
- Gail Attara, Gastrointestinal Society
- Ganive Bhinder, Better Pharmacare Coalition
- Laurie Proulx, Canadian Arthritis Patient Alliance
- Jaymee Maaghop, Canadian Cancer Survivor Network
- Christine Janus, International Association of Dermatology Patient Organizations
- Eric Lamoreaux, Canadian Patient Safety Institute
- Maureen Smith, Canadian Organization for Rare Disorders
- Angie Hamson, Patients for Patient Safety Canada
- Karen J. Kieley, Royal College of Physicians and Surgeons
- Caroline Herzberg, Canadian Dermatology Association
ASBM Advisory Board Chair Philip Schneider then presented a recap of the first two meetings, which were held in April and July of last year in Washington, DC. In these meetings, a strong consensus emerged on the importance of distinct naming and in favor of international harmonization. Health Canada in particular was a leading advocate of both.
Schneider then recounted several developments in the naming discussion that have occurred since the July meeting. First was the publication of the Scientific American whitepaper based on the April meeting, which may be read here. Second was ASBM’s participation in the 67th INN Consultation on October 13, 2018. Third was the publication of an article in the GaBI Journal emphasizing the benefits of the WHO’s Biological Qualifier (BQ) proposal for countries in the Middle East and North Africa region without robust pharmacovigilance systems of their own. The BQ would assign a 4-letter suffix to all biologics and biosimilars sharing an INN.
Dr. Schneider also shared objections to distinct naming- in particular to the WHO’s BQ proposal- that have been raised over the years, including that the system would be redundant, or might impede access, and proceeded to address them. For example, while advanced countries in Europe have robust pharmacovigilance systems, many developing nations do not. The Ministry of Health in the United Arab Emirates, Schneider noted, has expressed its support for the WHO’s BQ proposal, as have physicians in Latin America, 94% of whom consider it helpful in ensuring their patients receive the correct medicine.
As Dr. Schneider observed, this consultation and the resulting policy fails to adequately consider not only the perspectives of patients, but that of physicians.
For example, in a 2017 survey of 403 Canadian prescribers of biologics, ASBM found:
- 68% of physicians supported Health Canada assigning unique, distinct names to all biologics and biosimilars.
- Only 1% of these physicians said they identify the medicine in the patient record using the DIN.
- 20% record only the product’s non-proprietary name in the patient record, not the brand name. This can result in inadvertent or inappropriate substitutions, as well as the physician not being aware of which among a number of products the patient will be dispensed at the pharmacy.
- When reporting adverse events, only 4% of physicians use the DIN.
- When reporting adverse events, 26% record only the product’s non-proprietary name. This can result in misattribution of an adverse event to the wrong product.
- Only 23% of physicians consistently record batch/lot number when reporting adverse events.
FDA official Lubna Merchant, who attended the first two meetings, joined the meeting via teleconference.
Dr. Balocco also expressed hope that Canada’s decision would further underscore the urgent need for the WHO to take a leadership role on biologic naming and implement the BQ standard.
ASBM Chair Discusses Interchangeability, Need for Education
March 2, 2019
On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey.
Clips from the interview may be viewed here throughout the month of March.
Below is the first clip, in which Dr. Feldman discusses the concept of interchangeability, post-market challenges to biosimilar uptake, the importance of physician education on biosimilars.
