November 14, 2015
Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 states and Puerto Rico doing so this year.
November 14, 2015
Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 states and Puerto Rico doing so this year.
November 10, 2015
On November 10th, 2015 in Basel, Switzerland, ASBM’s Advisory Board Chair, University of Arizona pharmacy professor Philip J Schneider and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, participated in a debate on the subject of distinguishable naming for biosimilars.
The debate session, entitled “Naming conventions for biosimilar and subsequent labeling practices”, was part of the World Biosimilar Congress: Europe 2015 conference. Dr. Schneider and Mr. Spiegel argued that biosimilars should have names which allow them to be clearly distinguishable from their reference products as well as other approved biosimilars for that reference product.
“All biologics should have unique names, not just biosimilars- so patients and their doctors will always know which medicine the patient is receiving at the pharmacy when they make a treatment decision,” said Spiegel. “The FDA and the WHO both agree that distinguishable names are important for safety and tracking and patients want their doctors to have that information.”
Dr. Schneider noted that while there were still some details to work out- namely the structure and content of a biologic’s identifying suffix- he was optimistic about harmonizing regulations globally. “Giving [biosimilars] different names [from their reference products] just makes sense, since these are different-though similar- medicines…that’s why they are called ‘biosimilars‘ and not ‘generic biologics.”
On the other side were Everett Neville, Senior Vice President of Supply Chain for Express Scripts; and Hideaki Nomura, President and CEO of Fujifilm Kyowa Kirin Biologics; who argued that biosimilars, once approved, should share the same international nonproprietary name (INN) as their reference product.
Mr. Neville expressed skepticism that the code was necessary, and questioned whether physicians would consistently and correctly use such a code. Mr. Nomura expressed concern that the type of suffix proposed by the WHO and FDA would introduce more complexity and could potentially create confusion.
However, an ASBM survey of European biologic prescribers has shown the need for distingishability, with 24% of prescribers using only the INN to identify the medicine in the patient record- which could result in a patient receiving the wrong medicine. Further, 17% of prescribers report only the INN when reporting adverse events, which could result in their misattribution. Only 40% of EU physicians consistently recorded the product’s batch number when reporting adverse events, and 27% never did this.
One area of common ground among the two sides was concern over the value of suffixes comprised of random letters. Dr. Schneider and Mr. Spiegel supported the use of a suffix based upon the name of the product’s manufacturer or marketing authorization holder, as is currently the case with the sole biosimilar approved in the U.S., filgrastim-sndz. While supporting any distinguishing suffix rather than none at all, Dr. Schneider and Mr. Spiegel both considered manufacturer-based suffixes “easier to remember” for patients and providers than random suffixes. Dr. Schneider referenced a recent ASBM survey of 400 U.S. pharmacists which showed that 77% preferred the manufacturer based code to the random code, which was supported by only 15%; 8% had no opinion. Mr. Neville agreed that random codes had less value than manufacturer codes, observing that “patients don’t usually even know the [nonproprietary] name of the drug they’re on, they’re unlikely to remember a random code…a 4-digit random code isn’t helping anything.”
October 29, 2015
On October 27th, 2015, ASBM submitted comments on the FDA’s “Guidance for Industry Nonproprietary Naming of Biological Products”, released August 28th. The Draft Guidance called for distinguishable names for all biologic medicines, including biosimilars. This would be accomplished by use of a four-letter differentiating suffix composed of random letters.
In the comments, ASBM commended the FDA for its leadership on biologic naming and praised the FDA’s Draft Guidance, calling it ” a significant positive step” in advancing the goals of improved patient safety, pharmacovigilance, and understanding of biosimilars in the U.S. and globally.
“Physicians and pharmacists know that their ability to improve patient outcomes and safety is hampered unless they can clearly distinguish similar biologic medicines from one another”, the comments read in part.
Both the need for distinguishable naming and support for it among health providers has been documented by ASBM’s surveys of health providers in eleven countries. This included two recent surveys of 400 U.S. prescribers of biologics and 401 U.S. pharmacists.
The soon-to-be released U.S. prescriber survey, conducted in October 2015, revealed that two-thirds of physicians (66%) support the FDA issuing distinct nonproprietary names to all biologics, including biosimilars. Only 11 percent oppose this, while 23% had no opinion. A 2014 survey of 427 Canadian physicians had previously found that 79% supported the use of distinguishable names.
Additionally, 94% percent of the 399 biologic prescribers surveyed in Latin America this year supported the WHO’s BQ proposal (which like the FDA’s proposal would use a four-letter differentiating suffix) as a “useful” tool to help ensure that their patients receive the proper medicine.
This need and desire for clarity is not limited to physicians. ASBM’s October 2015 survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.
While in favor of differentiating suffixes, ASBM supports upon the name of the product’s manufacturer, as was the case with the FDA’s first biosimilar approval, Zarxio (filgrastim-sndz), rather than suffixes composed of random letters. Manufacturer-derived suffixes were supported by majorities of health providers surveyed (60% of physicians and 77% of pharmacists) because they are easier to remember and promote manufacturer accountability for their products.
The comments may be read in their entirety here.
The comments were signed by ASBM’s Chairman Harry Gewanter, its Advisory Board Chair Philip Schneider, its Steering Committee, and endorsed by 47 additional stakeholder groups.
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful
RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was presented in Latin America for the first time at the 2015 BIO Latin America Conference two days after sharing results from it with the World Health Organization (WHO) in Geneva, Switzerland.
The survey revealed that Latin American physicians overwhelmingly support the WHO’s Biological Qualifier (BQ) proposal, which would differentiate similar biologics from one another to ensure 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-letter code assigned to each product and appended to a shared root name, an approach similar to that recently proposed by the U.S. Food and Drug Administration (FDA).
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?”, 94% responded “Yes”. Physicians in Brazil had the strongest support, with 97% supporting the WHO’s proposal.
“Confusion can arise when two or more similar biologic medicines share the same International Nonproprietary Name (INN); this is a phenomenon we’ve documented globally,” said ASBM Chairman Harry Gewanter, MD, who presented the data.
The full Latin American survey, as well as previous ASBM surveys, are available at www.safebiologics.org.
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful
RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was presented in Latin America for the first time at the 2015 BIO Latin America Conference two days after sharing results from it with the World Health Organization (WHO) in Geneva, Switzerland.
The survey revealed that Latin American physicians overwhelmingly support the WHO’s Biological Qualifier (BQ) proposal, which would differentiate similar biologics from one another to ensure 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-letter code assigned to each product and appended to a shared root name, an approach similar to that recently proposed by the U.S. Food and Drug Administration (FDA).
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?”, 94% responded “Yes”. Physicians in Brazil had the strongest support, with 97% supporting the WHO’s proposal.
“Confusion can arise when two or more similar biologic medicines share the same International Nonproprietary Name (INN); this is a phenomenon we’ve documented globally,” said ASBM Chairman Harry Gewanter, MD, who presented the data.
The full Latin American survey, as well as previous ASBM surveys, are available at www.safebiologics.org.
October 14, 2015
For Immediate Release:
October 13, 2015
WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling.
“This survey reinforces what ASBM has been hearing from pharmacists through our Continuing Education programs and makes it clear that they prefer distinguishable names and more complete specific approval labeling for biologics than is currently called for by the FDA,” said Executive Director Michael Reilly.
When asked if the FDA should require distinct non-proprietary names for all biologics, including biosimilars, 68% of pharmacists replied “Yes”, 23% said “no”, and 8% had no opinion.
“These results are not surprising;” said Ronald P Jordan, Dean at Chapman University School of Pharmacy, Orange County, CA and former President of the American Pharmacists Association (APhA). “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”
Regarding the labeling of biosimilars, the ASBM survey reveals that pharmacists want greater transparency than the FDA currently requires. When asked to rate from 1-5 the importance of certain information being included on a biosimilar’s label, high percentages rated the following as a “4” or a “5”, indicating high importance for inclusion:
None of this information is currently present on the label of the only approved U.S. biosimilar, Zarxio (filgrastim-sndz).
“Pharmacists depend on the product label to advise patients and others on safe use, said Jordan. We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance.” Dean Jordan, who has served as a member of the ASBM Advisory Board since 2012, presented some of the data at the WHO’s 61st Consultation on International Nonproprietary Names (INN) today in Geneva.
The full pharmacist survey may be viewed here.
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:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
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October 13, 2015
Geneva, Switzerland – On October 13th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American physicians, 94% of whom supported the WHO’s Biological Qualifier (BQ) Proposal, which would assign a unique four-letter suffix to each biologic. A similar and potentially-compatible naming system was proposed by the U.S. Food and Drug Administration (FDA) in Draft Guidance released September 28th.
“Clear product identification is critical to physicians around the world, and it aids regulators in tracking the long-term safety and efficacy of these medicines. We are encouraged by the positive reception the BQ is receiving both from physicians and from other leading regulators like the FDA, and are honored to participate in its development”, said Gewanter.
Joining him to present the pharmacist perspective on biologic naming was Ronald P. Jordan, Dean of the Chapman University School of Pharmacy, former president of the American Pharmacists Association and current ASBM Advisory Board member.
Jordan shared data from ASBM’s survey of 401 U.S. pharmacists, which found 68% supported distinguishable naming for all biologics, including biosimilars.
“These results are not surprising;” said Jordan. “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”
ASBM has been very supportive of the WHO’s draft BQ proposal, providing data and testimony in the last several INN Open Sessions for Stakeholders, most recently the 60th Consultation held in April, and the INN’s Front Page Meeting held in June.
October 9, 2015
The Committee on Health Policy is shortly expected to begin hearings on House Bill 4812. HB 4812 was introduced by Rep. John Bizon, a physician, and contains many valuable protections such as patient notification, pharmacist-physician communication within 5 days of a substitution, and DAW (dispense as written) authority for the prescribing physician. The bill has garnered bipartisan support and has more than 20 cosponsors, including several representatives who are physicians. ASBM sent a letter of support for HB 4812 to Committee Chair Mike Callton and all Committee Members. A competing bill, HB 4437, introduced by Rep. Ken Yonker, contains some but not all of these elements, and while well-intentioned, it is ASBM’s position that this bill does not adequately address the safety and communication challenges of biosimilar substitution.
October 6, 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.
