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:
June 1st, 2015
SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015.
ASBM chairman Dr.Harry Gewanter provided the physician/patient perspective. Alex Waldron, VP of Global Commercial Operations for biosimilar manufacturer Epirus Pharmaceuticals; and Rakesh Dixit, VP of Research & Development and Global Head of Biologics Safety Assessment for innovator biologic company MedImmune, provided the perspectives of their industries. The panel was moderated by Bloomberg analysts Elizabeth Krutoholow and Aude Gerspacher, who released the results of a Bloomberg survey. The Bloomberg survey asked many diverse stakeholders in the biosimilars discussion about trends in the biosimilars market. Among the survey’s findings:
During the panel discussion, Dr. Gewanter presented the physician perspective– that transparency/clarity in naming and for purposes of identification and pharmacovigilance was an essential component of patient safety that should trump cost considerations- which was largely echoed by Rakesh Dixit of MedImmune, while Mr. Waldron of Epirus Pharmaceuticals challenged this view, suggesting that potential safety risks to patients need to be balanced against the potential benefits of increased access and potential savings to payers.
Dr. Gewanter’s presentation on physician perspectives was well received by the audience, which numbered around 70 attendees. Dr. Dixit asked Dr. Gewanter if major biotech companies possessed a competitive advantage in biosimilar production, to which Dr. Gewanter posed the analogy of VIZIO brand televisions- a new market entrant with a discount price point which needed to prove its quality to consumers relative to more established, familiar, and trusted brands. When asked by an audience member why the U.S. should not simply copy the European approach, Dr. Gewanter replied that there were lessons to be learned from Europe’s mistakes as well as their successes, and that more data and transparency, particularly in naming and labeling was needed to build physician confidence. In addition to making a strong case for distinguishable naming, Dr. Gewanter spent several minutes on the subject of labeling, highlighting physician concerns with the lack of labeling transparency regarding Zarxio.
In a separate presentation, pharmacist Doug Monroe (Project Manager for Biotechnology, Emerging Technology, and Specialty Pharmacy for Kaiser Permanente) provided a payer perspective. Dr. Monroe emphasized the process taken by the Pharmacy and Therapeutics (P&T) Committees within his company, which he described as being based upon a totality of scientific evidence from varied sources such as the FDA, the biosimilar sponsor, published reports from journals, and the European biosimilars experience.
Despite their varied perspectives, all the participants agreed on one matter: that building physician confidence in biosimilars was critical to their successful adoption.
May 21st, 2015
WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars.
In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS). ASBM was represented by its Chairman, pediatric rheumatologist Dr. Harry Gewanter; and its Executive Director, Michael S. Reilly.
Mr. Reilly described ASBM’s membership, and activities, and Dr. Gewanter provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.
Dr. Gewanter praised the FDA’s use of distinguishable naming in its first biosimilar approval of Zarxio (filgrastim-sndz), calling the differentiating suffix “helpful”. Dr. Gewanter noted its similarity to the World Health Organization’s (WHO’s) own proposal for distinguishable naming, the Biological Qualifier (BQ)-in which a biosimilar’s International Nonproprietary Name (INN) would consist of a suffix of random letters appended to the INN of its reference product. Gewanter, who recently participated in the WHO’s 60th Consultation on International Nonproprietary Names in April, praised the WHO’s international approach to clear naming: “We need a clear label and INN is a good choice because the issue is a global issue.”
Mr. Reilly echoed the need to find a global, rather than local, solution to the issue of biosimilar naming, praising the WHO’s approach and emphasizing that transparency in naming was key to successfully building physician confidence in biosimilars.
May 13th, 2015
On May 6, ASBM Chairman Harry Gewanter, M.D., sent a letter to Acting FDA Commissioner Stephen Ostroff, M.D, sharing ASBM’s recent survey on labeling and raising some concerns on the same issue.
Dr. Gewanter pointed out that the labeling for the recently approved biosimilar, Zarxio, falls short with the FDA’s longstanding emphasis on transparency and that clinically important product information is absent from the label. Dr. Gewanter said it is essential that the FDA include clear, appropriate and specific product labeling so patients and their healthcare team can make the best and most informed therapeutic decisions possible.
Read the letter here.
Physicians are not the only ones concerned with biosimilar labeling. On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in continuing education class with ASBM – also sent a letter to Stephen Ostroff expressing concerns. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and in the letter the pharmacists urged the FDA to consider a requirement for more informative labeling.
Read the letter here.
May 3rd, 2015
On April 23, Philip Schneider, University of Arizona College of Pharmacy professor, Ronald P. Jordan, Chapman University School of Pharmacy Dean and Joseph J. Bova, Director of Continuing Education at the Long Island University College of Pharmacy, sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug, on their concerns on biosimilar labeling. Jordan is former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and together the three pharmacists urged the FDA to consider a requirement for more informative labeling of biosimilars.
Read the letter here.
April 20th, 2015
On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients’ .
The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.
Read the full article here.
April 14th, 2015
Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.
This stakeholder session was the second time Dr. Gewanter was given the privilege to present and it was ASBM’s fourth time attending. ASBM was especially pleased that Dr. Schneider presented with Dr. Gewanter and was able to provide a pharmacist’s view on the topic of naming.
“We are so grateful for the opportunity to present at the WHO,” said Dr. Gewanter in his opening remarks. “Biosimilars’ high sensitivity to manufacturing differences, light, heat, denaturing; and their potential to stimulate unwanted immune reactions, means clear product identification is essential. ASBM believes that information, cooperation, communication and collaboration are vital to ensuring the best outcomes for patients across the globe. Implementing the WHO’s BQ proposal will make patient safety a priority.”
Dr. Schneider agreed that the BQ proposal would help ensure safety through clear product identification.
“All medicines, regardless of their similarity, should be easily identifiable,” said Dr. Schneider. “The pharmacy community has long advocated that drug names be clear to help avoid confusion and errors – and this could not be more true when it comes to highly complex biologic medicines. They must be easily distinguishable from each other and from other medicines. It is our hope that regulators around the world, including the FDA and EMA, adopt the BQ proposal by the WHO INN Programme, and its application within their jurisdictions.”
ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September of last year, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
For more information, please contact:
Alliance for Safe Biologic Medicines
Email: [email protected]
April 12th, 2015
Nigel Rulewski, MD, Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discusses the historic step the U.S. Food and Drug Administration (FDA) took on March 6, 2015 approving the first ever biosimilar product for the U.S. market.
Listen to the podcast here.