Posts – Page 51 – Safe Biologics

ASBM, Patient Groups Write Australia on Proposed Substitution Policy

July 6, 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.

ASBM Writes Letter to IL Governor Urging Signature on Substitution Bill

June 19, 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”.

These results are consistent with those of physicians surveyed around the world, including those in Canada and Europe, where biosimilars are currently in clinical use.

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.

Latin American Physicians Support Distinguishable Biosimilar Naming, Survey Finds

June 18, 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 51^st 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.

May-June 2015 Newsletter

June 6, 2015

ASBM Survey Shows Latin American Physicians Support Distinguishable Names

As the annual meeting of the Drug Information Association (DIA) June 15-18 in Washington DC, John Lewis of ASBM Steering Committee member the Association of Clinical Research Organizations (ACRO) presented data from ASBM’s physician surveys.

The surveys, of specialists in 11 countries from practice areas in which biologics are routinely prescribed, quantify physician perspectives on biosimilar naming, substitution, and labeling.

Lewis shared for the first time data from ASBM’s Latin American Survey (May 2015), including the fact that 94% of respondents supported the WHO’s BQ proposal.

Other recent data being presented to the DIA includes results from ASBM’s Canadian Survey (Dec. 2014), its U.S. Survey on Labeling (Feb. 2015), as well as a comparative analysis of all 11 countries surveyed.

The full Latin American survey results are available here.

ASBM Leadership, Members Attend WHO Meeting in Support of BQ Proposal

On June 16, the World Health Organization’s (WHO’s) Consultation on International Nonproprietary Names (INN) held its Front Page Meeting for Stakeholders at WHO headquarters in Geneva, Switzerland.

The meeting was held to finalize the WHO’s Biologic Qualifier (BQ) proposal, under which biosimilars would be made distinguishable from their reference products by the addition of a unique 4-digit code to the reference product’s INN.

Representatives from ASBM were in attendance, including Chairman Dr. Harry Gewanter, Advisory Board Chair Dr. Philip Schneider, and representatives from several member patient groups.

Please visit www.safebiologics.org for the latest updates on this meeting.

ASBM Cited in Royal Pharmaceutical Society Coverage of WHO Naming Debate

The work of ASBM in the global naming debate was heavily referenced in a June 11 Pharmaceutical Journal article previewing the June meeting and examining the status of biosimilar naming policies of various regulatory authorities including those of the EMA and FDA.

The Pharmaceutical Journal is published by the Royal Pharmaceutical Society, the membership body for pharmacists in Great Britain.

The article lays out a comprehensive picture of the naming debate, drawing heavily from ASBM’s work, including its research showing support for distiguishable naming among Canadian physicians. It also quotes ASBM Executive Director Michael S. Reilly extensively on the value of distinguishable naming, and discusses ASBM’s support for the WHO’s BQ proposal and its praise for the FDA’s use of a differentiating suffix in its first biosimilar approval, for Zarxio (filgrastim-sndz) March 2015.

Read the full article here.

ASBM Advisory Board Member’s Letter to Australian Health Minister Covered in PharmaDispatch

ASBM Advisory Board Member Stephen Murby, former Chair of the Consumers Health Forum and current biosimilars spokesperson for the International Alliance of Patients’ Organizations, has written a letter to Australian Health Minister Sussan Ley, reports PharmaDispatch in an article dated June 11th.

The letter addresses Mr. Murby’s concerns with indications given by the Australian government that it may begin to allow pharmacy-level substitution of biosimlars.

In his letter, Mr. Murby calls this “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.”

The letter was also sent to Shadow Health Minister Catherine King and Green Party Leader Senator Richard Di Natale.

Read the PharmaDispatch article here.

Second ASBM Pharmacist CE Class Success in CA

On May 29, ASBM held it’s second continuing education (CE) class for pharmacists at the Chapman University School of Pharmacy in Irvine, CA. The three-hour class, “Biosimilars: What Every Pharmacist Needs to Know,” educated pharmacists on the fundamentals of biosimilars by providing pharmacists with an overview of what biologics and biosimilars are, how they are manufactured and the regulatory challenges associated with them.

In his presentation, Ronald P. Jordan, BPharm, RPh, FAPhA and Dean of the Chapman University School of Pharmacy and former President of the American Pharmacists Association (APhA), who participated in the first CE class, thanked ASBM for organizing a similar offering on the West Coast that provided the pharmacy community with a critically important education on a very pressing issue.

Philip J. Schneider, M.S., F.A.S.H.P., Professor and Associate Dean for Academic and Professional Affairs, University of Arizona College of Pharmacy and ASBM International Advisory Board Chair; ASBM Chairman Dr. Gewanter and ASBM Executive Director Michael Reilly also presented.

ASBM Conducts CE Course for Pharmacists in CA

June 2, 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:

When asked “As a pharmacist, how important is it for me to be able to clearly distinguish between two similar biologic medicines?” 90% of respondents replied “Very Important or Critical”.
When presented with the statement “A biosimilar should have a name that allows it to be clearly distinguishable from the innovator or reference product to which it is similar.” 93% agreed with this statement.

ASBM Conducts CE Course for Pharmacists in CA

June 2, 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:

When asked “As a pharmacist, how important is it for me to be able to clearly distinguish between two similar biologic medicines?” 90% of respondents replied “Very Important or Critical”.
When presented with the statement “A biosimilar should have a name that allows it to be clearly distinguishable from the innovator or reference product to which it is similar.” 93% agreed with this statement.

Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 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:

Respondents overwhelmingly agreed that the most important guidance issued by FDA would be that regarding Interchangeability.
55% of respondents expected that biosimilars will have the same INN as their reference product with a batch number of biological qualifier.
When asked to estimate potential savings from biosimilars relative to innovator products, this was estimated to be in the 20%-40% range by the majority (71%) of respondents.

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.

Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 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:

Respondents overwhelmingly agreed that the most important guidance issued by FDA would be that regarding Interchangeability.
55% of respondents expected that biosimilars will have the same INN as their reference product with a batch number of biological qualifier.
When asked to estimate potential savings from biosimilars relative to innovator products, this was estimated to be in the 20%-40% range by the majority (71%) of respondents.

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.

ASBM Meets with Administration on Biosimilar Naming

May 21, 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.

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ASBM Meets with Administration on Biosimilar Naming

May 21, 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.

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