October 6th, 2015
On October 6, California Governor Edmund “Jerry” Brown signed into law SB 671, which permits pharmacists to substitute an interchangeable biosimilar in place of its reference product, provided the pharmacist communicates the substitution to the physician within five days time so that an accurate patient record is maintained, and the physician has not indicated “do not substitute” on the prescription. In a letter dated September 3rd,, ASBM urged Governor Brown, who had previously vetoed a similar bill, to support SB 671.
October 2nd, 2015
At the New York State Rheumatology Society 2015 Fall Meeting, held October 2nd in Saratoga, NY, ASBM presented a briefing entitled “Biosimilars: Regulatory Challenges and Physician Perspectives”. which discussed the current state of U.S. and international biosimilar regulation, including the topics of biosimilar naming, labeling, and substitution. ASBM shared survey data from physicans in eleven countries on these issues. Mr. Reilly also expressed his confidence the FDA will soon issue its long-awaited guidance on interchangeability, which would define the criteria a biosimilar must meet in order to be safely substituted for its reference product.
Mr. Reilly’s presentation may be viewed here.
All ASBM prescriber surveys may be viewed at www.safebiologics.org.
September 1st, 2015
The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival of biosimilars, so that any unexpected effects or adverse events can be attributed to the correct product and that non-interchangeable biosimilars are not inadvertently and/or inappropriately substituted.
It has long been ASBM’s view that distinguishable naming will allow physicians to maintain an accurate patient record, help pharmacists promote patient safety, improve adverse event reporting, and promote manufacturer accountability. Further, the four-letter differentiating suffix proposed by the FDA is potentially compatible with the four-letter Biological Qualifier (BQ) suffix proposed by the World Health Organization (WHO), which if adopted would extend the protections of distinguishable naming to patients throughout the world, regardless of in which country they receive treatment.
While the FDA’s proposed four-letter suffix will prevent unnecessary and potentially harmful ambiguities, there still remains room for improvement. In particular, the differentiating suffix deliberately designed to be “devoid of meaning” creates an unnecessary barrier to the use of distinguishable suffixes. It is ASBM’s position that a uniform and meaningful, intuitive suffix applied consistently to all products by a single manufacturer would be more memorable and thus easier for healthcare providers to use, limit proliferation of suffixes, and reduce the likelihood of juxtaposition or confusion. The four-digit code used in FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz), for example, is clearly based on the name of the biosimilar’s sponsor, Sandoz. Unlike the proposed random and meaningless suffix, “-sndz” is not only memorable and logical, but it promotes manufacturer accountability.
ASBM welcomes the chance to submit further comments on the draft guidance and once again thanks the FDA for their leadership in releasing biosimilar guidance that reflects its longstanding commitment to patient safety and transparency.
August 1st, 2015
On July 31, in Bend, Oregon, ASBM conducted a continuing education (CE) course for physicians, pharmacists, nurses, and other healthcare providers at six hospitals in the St. Charles Health System. Headquartered in Bend, Oregon, the system owns and operates St. Charles Madras, St. Charles Redmond, Pioneer Memorial Hospital, Blue Mountain Hospital, Lake District Hospital, and Harney District Hospital. The health system employs more than 3,000 people.
The course, entitled “Biosimilars: What Every Physician and Pharmacist Needs to Know” was presented by ASBM Executive Director Michael Reilly, and covered the definition of biologics and biosimilars, the difference between biosimilars and generic chemical drugs for purposes of patient care, associated regulatory challenges, and the importance of physician-pharmacist communication and cooperation.
“Biologic medicines are among the most powerful therapeutic tools healthcare providers have at their disposal to treat patients with serious conditions like rheumatoid arthritis and colorectal cancer,” said Reilly. “Biosimilars will soon provide them with new therapeutic options, potentially at reduced cost to their patients- but they also bring new challenges… learning about them is critical to providing quality care.”
Mr. Reilly’s presentation may be viewed here.
The 1-hour CE course was accredited by the Oregon Medical Association, the American Academy of Family Physicians, the Oregon Board of Pharmacy, and the California Board of Registered Nursing.
July 20th, 2015
In a letter dated July 20, 2015, ASBM Chairman Harry Gewanter, MD wrote FDA Acting Commissioner Stephen Ostroff MD on the need for all biologic medicines, including biosimilars, to be named so as to be easily distinguishable from one another. The FDA is expected to release its long-awaited guidance on biosimilar naming later this year.
In the letter, Dr. Gewanter praised the FDA’s recent use of a distinguishing suffix in its March approval of the first U.S. biosimilar, Zarxio (filgratim-sndz) calling it a “simple and eloquent solution” for identifying both the product and the legal entity responsible for its safety and efficacy (“-sndz” being based on the name of the product’s manufacturer, Sandoz).
Dr. Gewanter stressed than ASBM’s surveys of nearly 1700 prescribers of biologics found both a critical need and strong physician support for distinguishable naming:
Physician prescribing practices further showed that other attempts to ensure clear product identification, such as batch numbers and NDC codes, were shown by physician prescribing to be an inadequate solution:
ASBM examined the viability of NDC as a potential means of identification, but found only 0.3% of U.S. physicians used NDCs when identifying medicines in a patient record, and 0.5% when reporting adverse events. We also looked at the use of batch/lot numbers in countries with biosimilars and found that only 40% of European, and 26% of Canadian physicians consistently used batch numbers when reporting adverse events. Further, 45% of European and 27% of Canadian physicians never used them at all.
By contrast, distinguishable naming of biosimilars was overwhelmingly supported by physicians in two recent ASBM surveys. A 2014 found 79% of Canadian physicians supported Health Canada issuing distinguishable names for biosimilars. Similarly, a May 2015 survey found 94% of Latin American physicians supporting the World Health Organization’s (WHO’s) proposal to differentiate similar biologics with a four-letter differentiating suffix called a “biological qualifier” (BQ).
ASBM had previously shared the data with Administration officials in a May 19 meeting with Administration officials which included representatives from the U.S. Office Management and Budget (OMB), the Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS).
All ASBM surveys are available at www.safebiologics.org.
Dr. Gewanter’s letter to Acting Commissioner Ostroff may be read here.
July 17th, 2015
ASBM is pleased to announce the addition of Hepatitis Foundation International to its steering committee. The Foundation joins other patient and physician groups who help further the mission of organization which is to ensure the patient remains at the forefront of biologic and biosimilar policy making.
The Hepatitis Foundation International is a 501(c)3 non-profit organization established in 1994 working to eradicate chronic hepatitis for 400 million people globally. HFI is dedicated to increasing and promoting health and wellness; reducing the incidence of preventable liver-related chronic diseases, and lifestyles that negatively impact the liver. Some of these diseases include: obesity, diabetes, hepatitis, substance abuse, HIV/AIDS, cardiovascular disease and fatty/liver cancer. The HFI reaches well over 5 million patients and health care professionals annually through its public and private partnerships.
ASBM welcomes the international voice for the Hepatitis community to its steering committee to ensure the voice of the hundreds of millions affected by the disease are heard.
July 6th, 2015
On May 26, 2015 Australian Health Minister Sussan Ley announced that Australia would become the first nation in the world to allow so-called “automatic” substitution of biosimilars by pharmacists in place of the biologic prescribed by a physician. This move came at the recommendation of Australia’s Pharmacy Benefits Advisory Committee (PBAC).
In response to this development, ASBM and several member patient groups sent letters raising patient safety concerns to Minister Ley and other prominent officials in the Australian government, including members of the relevant Senate Committee in advance of its hearing on the matter.
Australia Breaks with Leading Regulators, Joining Venezuela in Permitting Pharmacy-level Substitution
The proposal would make Australia the only first-world country to allow pharmacy-level substitution of biosimilars. The practice is opposed by both the European Medicines Agency and Health Canada, the global leaders in in biosimilar approvals, both of which leave the determination of which biologic medicine a patient receives solely to their physician.
The practice is explicitly banned in many countries including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland. While France statutorily permits automatic substitution in certain limited cases, this policy has never been implemented.
The U.S. Food and Drug Administration, which approved its first biosimilar in March, has not yet determined what safety and efficacy data it would require from a biosimilar’s sponsor in order to demonstrate that it could be safely substituted for its reference product.
Only Venezuela currently permits the practice.
ASBM Surveys Find Global Physician Opposition to Automatic Substitution
ASBM’s letter to Minister Ley cites data from four surveys of biologic-prescribing specialists in 11 countries. These data show that most prescribers of biologics (62% of the European physicians, 71% of the Canadian physicians and 85% of Latin American physicians) consider a pharmacy-level determination of which biologic to dispense to their patient to be “unacceptable”.
Additionally, notification in the event of a biosimilar substitution was considered “very important” or “critical” by 80% of U.S., 77% of European, 85% of Canadian, and 87% of Latin American physicians surveyed.
The ability to prevent a substitution by indicating “do not substitute” or “dispense as written” on the prescription was considered “very important” or “critical” 82% of U.S., 74% of European, 80% of Canadian, and 85% of Latin American physicians surveyed.
All ASBM surveys are available at www.safebiologics.com.
This concern among physicians is also reflected in comments by Australian Rheumatology Association (ARA) President Dr Mona Marabani who warned of patient safety concerns:
The proposed new powers will allow pharmacists to switch particular drugs at the pharmacy counter with the potential for patients to get a different drug every time they go to the chemist…Advisory bodies within Australia (e.g. Council of Australian Therapeutic Advisory groups) and leading regulators around the world do not advise switching these drugs, as we do not know if it is safe.
Patient Advocates Share Safety Concerns
Australian patient advocate and ASBM Advisory Board member Stephen Murby wrote a letter to Minister Ley in which he said of the move:
Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia. One which is completely out-of-kilter with world best practice and which has the potential to reduce the standards of safe use of biosimilars for patients.
Two ASBM Steering Committee members also sent letters to Minister Ley and the Australian Senate:
The Global Colon Cancer Alliance (GCCA), sent a letter opposing pharmacy-level substitution of biosimilars “until these medicines have been sufficiently evaluated for safety and efficacy, including repeated switching between products — whether it be between the reference biologic and a biosimilar or between two biosimilars.”
The International Cancer Advocacy Network (ICAN) also sent a letter to Minister Ley, in which ICAN President Marcia Horn highlighted ICAN’s safety concerns and suggested that contrary to expectations, substitution without physician involvement could actually increase costs:
For all patients who do not respond to the originally intended treatment, and especially those patients who suffer adverse reactions, [due to substitution without physician involvement] physicians would be in the dark as to the cause. This will require precious physician time, additional diagnostic tests, and in the cases of significant reactions, hospitalization.
ASBM will continue to monitor developments in Australia as they develop.
June 19th, 2015
On Friday, June 19, ASBM sent a letter to Illinois Governor Bruce Rauner urging him to sign SB 0455, which would permit biosimilar substitution. It is ASBM’s view that SB 0455 does so while appropriately reflecting the importance of pharmacist-physician communication and keeping treatment decisions the purview of the physician and patient.
ASBM’s survey of 376 U.S. physicians found that 80% of those surveyed called notification in the event of a biosimilar substitution “very important” or “critical”.
Further, 82% of U.S. physicians called the authority to block a substitution by indicating “do not substitute” or “dispense as written” on a prescription “very important” or “critical”.
SB 0455 received no negative votes in any committee, and the legislation ultimately passed the House 112-0-0 and the Senate 58-0-0.
ASBM’s letter to Governor Rauner may be read here.
June 18th, 2015
Brazil, Mexico lead with 97% support for WHO’s BQ Proposal
Washington, DC- The Alliance for Safe Biologic Medicines (ASBM) today presented at the 51st Annual Meeting of the Drug Information Association (DIA). The presentation, titled “Physician Perspectives on Biosimilars” was given by John Lewis, Senior Vice President of the Association of Clinical Research Organizations, an ASBM Steering Committee member. Physician data regarding biosimilars was shared from five surveys and eleven countries, including for the first time the results of ASBM’s recent survey of Latin American physicians.
The Latin American survey, conducted May 2015, examined the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. Respondents were selected almost exclusively from six specialties in which biologic medicines are routinely prescribed: Dermatology, Endocrinology, Nephrology, Neurology, Oncology, and Rheumatology.
Most notably, the survey revealed that Latin American physicians overwhelmingly support the World Health Organization’s Biological Qualifier (BQ) proposal, which would allow biosimilars to be clearly distinguishable from the reference products upon which they are based for purposes of clear prescribing, dispensing, and long-term tracking of safety and efficacy. Under the BQ proposal this would be accomplished by the addition of a 4-digit code appended to the product’s International Nonproprietary Name (INN).
When asked “Do you think [the WHO’s proposed] “biologic qualifier” would be useful to you to help you ensure that your patients receive the right medicine that you have prescribed for them?”, a full 94% responded “Yes”.
Physicians in Brazil and Mexico had the strongest support, with 97% supporting the WHO’s proposal, while the lowest level of support found was among Colombian physicians, 89% of whom were in favor of the BQ.
These results are not surprising, explained Lewis: “Physicians need to clearly identify which medicine their patient is receiving in order to give them proper care. Last year ASBM surveyed physicians in Canada, where biosimilars are available, and found 79% supported distinguishable names.”
Physician prescribing practices also highlight the value of distinguishable names. A full 57% of respondents refer to a medicine exclusively by its nonproprietary name in a patient record, which could result in a patient receiving the wrong medicine.
Similarly, 28% of physicians surveyed indicated that they use the nonproprietary name exclusively when reporting adverse events, which could result in attribution to the wrong medicine.
The full results of the Latin American survey may be viewed here.
June 2nd, 2015
On May 29, 2015, in partnership with the Chapman University School of Pharmacy, ASBM held a Continuing Education course for roughly 40 pharmacists entitled “BIOSIMILARS: WHAT EVERY PHARMACIST SHOULD KNOW” at Chapman’s campus in Irvine, CA.
Following a brief baseline quiz to determine the participants’ understanding of biologics and biosimilars, four presentations were given by ASBM as part of a 3-credit hour course accredited by the California Pharmacists Association:
ASBM executive director Michael Reilly covered the history of U.S. biosimilar regulation, emphasizing on legislative definitions and FDA guidance, along with the broad strokes of ASBM’s activities serving as a resource for physician, patient and pharmacist perspectives for regulators in the U.S. and internationally. View his presentation here.
ASBM advisory board chair Dr. Philip Schneider covered the scientific differences between biologics and chemical medicines, illustrating how the size and complexity of these molecules, along with their sensitivity and lability, pose unique challenges including the possibility of immune response, and require special care in handling and preparation. The importance of clear identification of two similar biologics was emphasized from a pharmacist perspective, and possible solutions to this need (random or meaningful suffixes, prefixes, NDC codes, BQ) were discussed. The value of clear labeling was emphasized and identified as critical for pharmacists. Dr. Schneider also discussed the reason he co-authored a letter to the FDA calling for transparent biosimilar labeling. View his presentation here.
ASBM chairman Dr. Harry Gewanter then shared survey data reflecting physicians views on the importance of transparency in medicines, including the value of distinguishable names and a transparent label. Dr. Gewanter spoke about the value, hope, and opportunity that biologic medicines have brought to his patients, emphasizing that biosimilars will add to their legacy and increase access as well. However, he cautioned that physicians must gain confidence in biosimilars through data and transparency. Dr. Gewanter also stressed the need for timely physician-physician communication in cases of biosimilar substitution. View his presentation here.
Finally, Dr. Schneider discussed the evolution and current status of biosimilar substitution legislation in the U.S. He stressed the common ground between physicians and pharmacists, and value of cooperation and collaboration with physicians for general purposes of patient safety and pharmacovigilance. View his presentation here.
Following the course, an informal survey was conducted to measure the participants’ attitudes toward biosimilar naming. The results showed that the pharmacists in attendance were extremely supportive of distinguishable naming: