ASBM President Doug Badger, left, and Advisory Board Chair Philip Schneider, at the WHO Headquarters in Geneva, Switzerland, October 18th, 2016
On October 18th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP participated in the World Health Organization’s 63rd Stakeholder Consultation on International Nonproprietary Names.
The subject of the INN meeting is the continued development of the INN Programme’s Biologic Qualifier (BQ) proposal. The is a modification to the INN system designed to ensure clear product identification between biosimilars and their reference product by means of a four-letter distinguishing suffix appended to a common root name. This is the eighth INN Consultation at which ASBM has shared its perspectives with the INN Expert Group.
As a condition of participation, ASBM was asked by the WHO to refrain from discussing details about the meeting until the Executive Summary is made available to the public in the coming months.
The Executive Summary from the 62nd INN Consultation, held on April 12th, may be viewed here, and ASBM’s presentation from that meeting may be viewed here.
On October 12th, in Toronto, Ontario, ASBM participated in an educational webinar for the Ontario Hospital Association, which represents 150 hospitals in the Canadian province. ASBM Executive Director Michael Reilly participated on a panel with Canadian physicians, patients, and industry representatives. Around 100 attendees were present.
Mr. Reilly discussed the state of biosimilar uptake globally. He described U.S. and European polices on biosimilar approval, naming and substitution, and how they compare and contrast to those of Canada.
On October 5th, ASBM Executive Director Michael Reilly and Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, met with Health Alberta regulators to offer ASBM’s perspectives on Canadian biosimilar policy. Reilly and Spiegel shared data from ASBM’s survey of Canadian prescribers. ASBM counts 12 Canadian patient groups among its membership, and ASBM member IAPO represents 10 Canadian member groups.
The primary purpose of the meeting was to discuss Alberta’s consideration of the automatic switching of naive patients to the biosimilar Inflectra for cost, rather than medical reasons. Unlike chemical generics, biosimilars are not identical to their reference products; thus, Non-Medical Switching is of great concern to patients treated with biologics.
ASBM also met with Drew Barnes, a Member of the Legislative Assembly, to discuss these concerns. MLA Barnes is Chief Opposition Health Critic in the Alberta Legislature.
The following day, October 6th, Mr. Reilly and Mr. Speigel participated in a biosimilars forum held by Canada’s Institute for Health Economics, where Mr. Reilly spoke at a breakout session. While critical of provincial NMS policies, Mr. Reilly praised Canada’s overall record on biosimilars. “Health Canada has been very patient-centric when approving biosimilars, particularly in its caution regarding indication extrapolation, but also in its support for the WHO’s distinct naming plan and its biosimilar labeling guidance, which leads the world in its transparency requirements, ” said Reilly.
On September 30th, An op-ed appeared in the Detroit News, authored by Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN), an ASBM Steering Committee member. Ms. Horn discusses how legislation permitting biosimilar substitution could help Michigan patients. Similar legislation has been passed in 25 states and Puerto Rico. A key provision of the legislation is a requirement for pharmacists to communicate in a timely manner which biologic- the originator product or the biosimilar- was dispensed to the patient. This allows an accurate patient record to be kept, and for the patient’s response to treatment to be accurately assessed by the physician.
ASBM Chairman Harry Gewanter MD, and Andrew Spiegel, executive director of the Global Colon Cancer Association; both testified Jan 19th, 2016 in support of HB 4812 in a Michigan Senate Health Committee hearing. The bill had passed the Michigan House of Representatives 101-5 in November 2015, but the provision requiring communication between pharmacist and physician was ultimately stripped from the Senate version.
On Friday, September 23rd the FDA approved its fourth biosimilar, Amjevita (adalimumab-atto).
Amjevita (adalimumab-atto) was approved for seven adult indications of its reference product, Humira (adalibumab):
moderately to severely active rheumatoid arthritis;
active psoriatic arthritis;
active ankylosing spondylitis (an arthritis that affects the spine);
moderately to severely active Crohn’s disease;
moderately to severely active ulcerative colitis; and
moderate to severe plaque psoriasis.
Like the three previously-approved biosimilars, Amjevita (adalimumab-atto) is not approved as interchangeable. Only an interchangeable biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.
Read the FDA’s Press Release about that approval here.
SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and neurological conditions. The forum, entitled “What Patients Need to Know About Biologic Medicines and Biosimilars” was held as part of the 3rd Brazilian Congress All Together Against Cancer and was attended by more than 300 patient advocates, mostly from Latin America.
Mr. Spiegel offers patient perspectives on biosimilars.
Andrew Spiegel, executive director of GCCA and a founding member of ASBM, moderated the two-hour discussion about biosimilars- attempts to create lower-cost copies of biologic medicines which treat serious conditions like rheumatoid arthritis, psoriasis, and a variety of cancers. Unlike generic versions of chemical drugs, biosimilars are not exact copies of the originator products- they are merely “similar”. These differences can create unexpected effects in patients, including unwanted immune responses. Polices regarding their use must reflect these concerns, Mr. Spiegel argued: “Biosimilars hold great promise for patients in Latin America, offering them new choices at lower cost- but in order to realize these benefits, patient and physicians need to be confident in their safety and effectiveness”.
Valderílio Azevedo MD, rheumatologist from the Federal University of Paraná, and ASBM Chairman Harry L Gewanter MD provided the physician perspective on biosimilars.
ASBM Chairman Harry L Gewanter MD shares data from a survey of 399 biologic prescribers in four Latin American countries.
Dr. Gewanter shared results of a survey of 399 prescribers of biologic medicines from four Latin America countries: Argentina, Brazil, Colombia and Mexico. ASBM recently presented these data to the XIX Pan American League of Associations for Rheumatology Congress in Panama City, Panama in April; and at the 6th Latin American Forum on Biosimilars in Brasília, Brazil in June.
The survey revealed a need for clear naming for all biologics, including biosimilars: 57% of respondents referred to a biologic medicine exclusively by its non-proprietary name in a patient record (which could result in patients receiving the wrong medicine). Further, some 28% used the non-proprietary name exclusively when reporting adverse events (which could result in attribution to the wrong medicine).
From left to right: Zorana Moravic of EuropaColon, Barry Stein of the Colorectal Cancer Association of Canada, Luciana Holtz of Brazil’s Oncoguia Institute, Andrew Spiegel of the Global Colon Cancer Association, and ASBM Chairman Harry Gewanter MD.
The World Health Organization (WHO), which issues international non-proprietary names, has proposed to differentiate similar medicines from one another by the use of a biological qualifier (BQ), a unique four-letter code added to a shared root name. The survey revealed that 94% of respondents considered the BQ “useful in helping ensure their patients receive the right medicine”.
Carolina Cohen, Director of ABRALE, the Brazilian Association for Lymphoma and Leukemia, an ASBM member which idealized and organized the larger conference, emphasized the need for patients and physicians to educate themselves about biosimilars, and to engage their regulatory authorities. “Currently the level of patient protections in biosimilar policy varies widely from country to country. ABRALE believes that patients should be able to expect safe and effective biosimilars in whichever country they receive treatment. ASBM has worked globally since 2010 to educate on these medicines and promote their safe use.”
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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
SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and neurological conditions. The forum, entitled “What Patients Need to Know About Biologic Medicines and Biosimilars” was held as part of the 3rd Brazilian Congress All Together Against Cancer and was attended by more than 300 patient advocates, mostly from Latin America.
Mr. Spiegel offers patient perspectives on biosimilars.
Andrew Spiegel, executive director of GCCA and a founding member of ASBM, moderated the two-hour discussion about biosimilars- attempts to create lower-cost copies of biologic medicines which treat serious conditions like rheumatoid arthritis, psoriasis, and a variety of cancers. Unlike generic versions of chemical drugs, biosimilars are not exact copies of the originator products- they are merely “similar”. These differences can create unexpected effects in patients, including unwanted immune responses. Polices regarding their use must reflect these concerns, Mr. Spiegel argued: “Biosimilars hold great promise for patients in Latin America, offering them new choices at lower cost- but in order to realize these benefits, patient and physicians need to be confident in their safety and effectiveness”.
Valderílio Azevedo MD, rheumatologist from the Federal University of Paraná, and ASBM Chairman Harry L Gewanter MD provided the physician perspective on biosimilars.
ASBM Chairman Harry L Gewanter MD shares data from a survey of 399 biologic prescribers in four Latin American countries.
Dr. Gewanter shared results of a survey of 399 prescribers of biologic medicines from four Latin America countries: Argentina, Brazil, Colombia and Mexico. ASBM recently presented these data to the XIX Pan American League of Associations for Rheumatology Congress in Panama City, Panama in April; and at the 6th Latin American Forum on Biosimilars in Brasília, Brazil in June.
The survey revealed a need for clear naming for all biologics, including biosimilars: 57% of respondents referred to a biologic medicine exclusively by its non-proprietary name in a patient record (which could result in patients receiving the wrong medicine). Further, some 28% used the non-proprietary name exclusively when reporting adverse events (which could result in attribution to the wrong medicine).
From left to right: Zorana Moravic of EuropaColon, Barry Stein of the Colorectal Cancer Association of Canada, Luciana Holtz of Brazil’s Oncoguia Institute, Andrew Spiegel of the Global Colon Cancer Association, and ASBM Chairman Harry Gewanter MD.
The World Health Organization (WHO), which issues international non-proprietary names, has proposed to differentiate similar medicines from one another by the use of a biological qualifier (BQ), a unique four-letter code added to a shared root name. The survey revealed that 94% of respondents considered the BQ “useful in helping ensure their patients receive the right medicine”.
Carolina Cohen, Director of ABRALE, the Brazilian Association for Lymphoma and Leukemia, an ASBM member which idealized and organized the larger conference, emphasized the need for patients and physicians to educate themselves about biosimilars, and to engage their regulatory authorities. “Currently the level of patient protections in biosimilar policy varies widely from country to country. ABRALE believes that patients should be able to expect safe and effective biosimilars in whichever country they receive treatment. ASBM has worked globally since 2010 to educate on these medicines and promote their safe use.”
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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
To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz).
The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable names over random because they are easier to recognize and remember.
Yet there’s another reason for the FDA to stick with the original meaningful/manufacturer-based naming system over random: it’s a far better means of promoting manufacturer accountability.
Think of red-light cameras. You probably don’t run many red lights, but do the cameras make you more likely to stop for a red light, knowing that your infraction will be certainly and immediately traced to you? Sure they do. Likewise, manufacturer-based names for biosimilars will incentivize the manufacturer to make a product they can stand by, since a problem with the medicine will certainly and immediately reflect poorly on the company’s name and reputation.
As a former regulator at HHS, part of my job was holding insurers accountable for the decisions they made regarding Medicare beneficiaries. For example, I helped create a system by which patients who were denied Medicare-approved treatments by a private insurer could appeal those decisions. Providers who were found to be abusing the system faced swift consequences- up to and including being banned from further Medicare contracts. We designed a system where the increased likelihood of negative consequences promotes good health outcomes for patients and good behavior among contractors.
Put simply, compliance with regulations is higher when there is a more credible chance of negative consequences – whether it be a traffic ticket, or a reputation as a manufacturer that provides substandard products or services to their patients.
Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. He served in the Secretary’s Office at the U.S. Department of Health and Human Services (HHS) from 2002-2008, including three years as Associate Deputy Secretary.
To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz).
The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable names over random because they are easier to recognize and remember.
Yet there’s another reason for the FDA to stick with the original meaningful/manufacturer-based naming system over random: it’s a far better means of promoting manufacturer accountability.
Think of red-light cameras. You probably don’t run many red lights, but do the cameras make you more likely to stop for a red light, knowing that your infraction will be certainly and immediately traced to you? Sure they do. Likewise, manufacturer-based names for biosimilars will incentivize the manufacturer to make a product they can stand by, since a problem with the medicine will certainly and immediately reflect poorly on the company’s name and reputation.
As a former regulator at HHS, part of my job was holding insurers accountable for the decisions they made regarding Medicare beneficiaries. For example, I helped create a system by which patients who were denied Medicare-approved treatments by a private insurer could appeal those decisions. Providers who were found to be abusing the system faced swift consequences- up to and including being banned from further Medicare contracts. We designed a system where the increased likelihood of negative consequences promotes good health outcomes for patients and good behavior among contractors.
Put simply, compliance with regulations is higher when there is a more credible chance of negative consequences – whether it be a traffic ticket, or a reputation as a manufacturer that provides substandard products or services to their patients.
Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. He served in the Secretary’s Office at the U.S. Department of Health and Human Services (HHS) from 2002-2008, including three years as Associate Deputy Secretary.
On September 15th, 2016, ASBM held an educational forum at the University of the Sciences in Philadelphia (USciences). The program drew 50 attendees comprised of pharmacists, faculty members, pharmacy students.
The program began with an introduction to biosimilars from USciences Associate Professor of Pharmaceutical Sciences Dr. Zhiyu Li. Dr. Li is Director of Undergraduate Pharmacology/Toxicology Program, where he teaches courses on Biomethods in Pharmacology and Toxicology and Biopharmaceutical Proteins.
In order to demonstrate the size and complexity of biologic medicines, Dr. Li described a small-molecule drug (such as aspirin) as being like a bicycle in terms of complexity, whereas a biologic medicine (such as a monoclonal antibody) is more comparable to an airplane.
Dr. Li describes the greater size and complexity of biologic medicines, relative to traditional chemical drugs.
He then explained that this complexity, and the process by which biologics are grown in living cells, mean that biosimilars can only ever be similar to their reference products- never identical. Even biosimilars grown using an identical sequence as its reference product can result in different end products, likening the two products to twins which look nearly identical yet have different personalities, or the same dish prepared by two different chefs.
ASBM Advisory Board chair Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy, then discussed biosimilars from the perspective of healthcare providers. Dr. Schneider drew upon ASBM surveys of physicians and pharmacists, and more than thirty years’ experience as a professor of pharmacy.
Schneider focused on three main challenges facing policymakers in regard to biosimilars: how they will be named, under what circumstances they may substituted for their reference product, and what information will their labeling include.
Regarding naming, ASBM surveys show that physicians (66%) and pharmacists (68%) overwhelmingly support distinct names for all biologic medicines, including biosimilars. Both the FDA and World Health Organization have proposed accomplishing this by use of a four letter suffix. Of the three biosimilars approved by the FDA, one uses a meaningful suffix derived from its manufacturer’s name-and two use random suffixes.
An informal poll of the audience showed strong support for the meaningful suffix, with most hands raised- by contrast, only one hand was raised in favor of random suffixes. Similarly, an ASBM survey of 400 pharmacists showed 77% support meaningful, memorable suffixes.
“Who here supports random suffixes?” Dr. Schneider asked the audience.
Regarding the labeling of biosimilars, Dr. Schneider emphasized the need for informative, transparent labeling that allows physicians and pharmacists to make informed treatment decisions.
Finally, Dr. Schneider discussed how many states- most recently Pennsylvania- allow substitution of “interchangeable” biosimilars- those shown to provide the same results as the reference product without additional risks. The Pennsylvania law, he explained, reflects the importance of good communication between healthcare providers- so that the physician always knows which medicine is dispensed to the patient at the pharmacy, and the patient’s response to a treatment can be accurately assessed. Currently, 24 states and Puerto Rico have enacted similar legislation.
Dr. Schneider discusses interchangeability. Only interchangeable biosimilars may be substituted by pharmacists.
The final speaker was Andrew Spiegel, Executive Director of the Global Colon Cancer Association. Mr. Spiegel discussed the tremendous benefits that biosimilars will bring patients- including new treatment choices and reduced healthcare costs- but cautioned that the decision to switch must always remain with the patient and physician, rather than a third party such as a government or insurer. Mr. Spiegel provided several examples of how insurance companies can force patients to switch medicines. This is especially worrisome with biosimilars that are not approved by the FDA as “interchangeable” with their reference product. Many patients with the serious, chronic conditions biologic medicines are used to treat struggle for years and try multiple products before becoming stable. Switching a patient’s medicine for reasons other than health and safety is referred to as Non-Medical Switching, and many patient organizations have raised these concerns when testifying before the FDA.
“Patients and physicians should make the treatment decisions” said Mr. Spiegel. “They are concerned only with what’s best for the patient…other entities may have different objectives, including profit or budgetary concerns.”
Additionally, he noted that transparency about how a biosimilar was approved is critical to helping patients make informed choices. For example, the FDA recently approved Inflectra (infiximab-dyyb) for all indications of its reference product for which it applied, despite having demonstrated biosimilarity only in two of the indications- a process called indication extrapolation. By contrast, Health Canada required additional clinical data before granting approval for the extrapolated indications two years later.
Mr. Spiegel discusses the need for caution when approving biosimilars for an indication in the absence of clinical data in that indication.
