January 2019 Newsletter
February 1, 2019
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Statement from ASBM Executive Director Michael Reilly in Response to a Mischaracterization of ASBM’s Work in January 10 Washington Post Article
January 16, 2019
On January 10, 2019, the Washington Post published an article “Patients stuck in corporate fight against generic drugs.” I spoke extensively with the author of the article and also suggested that he speak with the Chair of the Alliance for Safe Biologic Medicines (ASBM) international advisory board Dr. Philip Schneider. Unfortunately, the article did not represent the information that was shared by me and Dr. Schneider about the work of ASBM. Instead it attempted to portray ASBM as an organization seeking to “create confusion about the safety and effectiveness of unbranded biologic drugs” which is an assertion that cannot be credibly made in light of ASBM’s record.
Since 2013, ASBM has been involved in efforts to pass state legislation that is intended to increase access to biosimilars by allowing pharmacists to automatically substitute interchangeable biosimilars once approved by the FDA without consulting with the prescribing physician–provided the physician is notified within 72 hours. This legislation is consistent with the position of the FDA and removes the prior authorization or notification barrier that can delay access to biosimilars. We have provided testimony either in written form or in-person in each of the 45 states where these laws have been passed.
ASBM has, from its inception in 2010, been focused on serving as a resource for regulators and policymakers in order to help establish a robust biosimilars program that will ultimately increase access and reduce the cost of medicine for patients and governments worldwide. I have served as the Executive Director of ASBM since it was formed. Our focus on affirmatively establishing – not thwarting – a pathway for biosimilars, including substitution when appropriate – was built on my experience in government, including three tours at the U.S. Department of Health and Human Services (HHS) under the 41st, 42nd and 43rd Presidents. I served my final tour at HHS working in the Office of the Secretary from 2002 to 2008 and know from firsthand experience how important thoughtful participation by informed experts is to sound public policy.
Since 2010, ASBM has participated in more than 50 meetings with regulators worldwide to discuss policy issues and challenges around biosimilars. In every instance, ASBM has begun with the underlying and fundamental assertion that biosimilars are an important tool in the attempt to increase access and reduce the cost of medicines. We have provided in-person testimony to the FDA on at least 15 occasions during that time. I have participated on panels discussing biosimilar policy with regulators in Berlin, Brussels, Canberra, Dublin, Geneva, Madrid, Ottawa, Paris, and Rome and met directly with senior government officials from the European Commission (Brussels), European Medicines Agency (EMA), FDA, Health Canada, Italian & Spanish Ministries of Health, Therapeutic Goods Administration (TGA) and World Health Organization (WHO). We have conducted 14 physician surveys in 12 countries and shared the results of those surveys directly with the regulators in the countries surveyed. All of the surveys are publicly available on our website www.safebiologics.org/surveys.
ASBM will continue to serve as a resource for policymakers and regulators in the U.S. and across the globe as they attempt to build a robust and sustained biosimilars program that will benefit patients worldwide.
Michael Reilly
Executive Director, ASBM
ASBM Advisory Board Chair Responds to Mischaracterization of Comments in Washington Post
January 14, 2019
by Philip Schneider, MS FASHP FFIP
Advisory Board Chair, Alliance for Safe Biologic Medicines
This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post.
My comments that were misinterpreted in this article arose from a discussion about the importance of duly considering safety and effectiveness, in addition to cost, when making decisions about the choice of drug therapy. My mention of thalidomide was in reference to a seminal event that made ensuring the safety of drugs and other medical products a priority for the FDA and to show how the FDA has ably fulfilled this mission in the ensuing decades. In no way was I linking biosimilars to the thalidomide experience. The basic underpinning of every presentation I have ever given, comments I have submitted or testimony I have provided is that all biosimilars are to be considered “safe and effective” once approved by the FDA.
By way of background, I was interviewed as chairman of the international advisory board of the Alliance for Safe Biologic Medicines (ASBM). In this capacity, I represent an organization that since 2010 has promoted biosimilars as a strategy to increase access to new breakthrough biologic therapies.
I bring to my role with ASBM more than forty years of experience in academic health sciences centers as both a practitioner and faculty member; I have never been an employee of the pharmaceutical industry. My comments regarding the safety of biosimilars were taken out of context and wrongly portrayed. I have testified on behalf of ASBM in many states in support of legislation that authorizes pharmacists to automatically substitute less expensive interchangeable biosimilars approved by the FDA; legislation that has now been passed in 45 of 50 states in the US.
I have also testified on eight occasions to the World Health Organization in support of their Biologic Qualifier program that assigns distinguishable non-proprietary names to biosimilars to improve confidence in their use among prescribers, pharmacists, and patients to speed uptake. I have conducted many continuing education programs for health care professionals promoting the safe use of biosimilars; something quite inconsistent with the impression left in the Washington Post article.
Let me be clear: I support the availability and use of biosimilars. By taking one of my comments out of context, the article misleads readers into believing that I oppose them. I am writing this to correct this irresponsible reporting by the Post.
ASBM Advisory Board Chair Responds to Mischaracterization of Comments in Washington Post
January 14, 2019
by Philip Schneider, MS FASHP FFIP
Advisory Board Chair, Alliance for Safe Biologic Medicines
This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post.
My comments that were misinterpreted in this article arose from a discussion about the importance of duly considering safety and effectiveness, in addition to cost, when making decisions about the choice of drug therapy. My mention of thalidomide was in reference to a seminal event that made ensuring the safety of drugs and other medical products a priority for the FDA and to show how the FDA has ably fulfilled this mission in the ensuing decades. In no way was I linking biosimilars to the thalidomide experience. The basic underpinning of every presentation I have ever given, comments I have submitted or testimony I have provided is that all biosimilars are to be considered “safe and effective” once approved by the FDA.
By way of background, I was interviewed as chairman of the international advisory board of the Alliance for Safe Biologic Medicines (ASBM). In this capacity, I represent an organization that since 2010 has promoted biosimilars as a strategy to increase access to new breakthrough biologic therapies.
I bring to my role with ASBM more than forty years of experience in academic health sciences centers as both a practitioner and faculty member; I have never been an employee of the pharmaceutical industry. My comments regarding the safety of biosimilars were taken out of context and wrongly portrayed. I have testified on behalf of ASBM in many states in support of legislation that authorizes pharmacists to automatically substitute less expensive interchangeable biosimilars approved by the FDA; legislation that has now been passed in 45 of 50 states in the US.
I have also testified on eight occasions to the World Health Organization in support of their Biologic Qualifier program that assigns distinguishable non-proprietary names to biosimilars to improve confidence in their use among prescribers, pharmacists, and patients to speed uptake. I have conducted many continuing education programs for health care professionals promoting the safe use of biosimilars; something quite inconsistent with the impression left in the Washington Post article.
Let me be clear: I support the availability and use of biosimilars. By taking one of my comments out of context, the article misleads readers into believing that I oppose them. I am writing this to correct this irresponsible reporting by the Post.
ASBM Exhibits at the ASHP Midyear Meeting
December 12, 2018
December 3rd-5th, ASBM exhibited at the Midyear Meeting of the American Society of Health-system Pharmacists (ASHP) in Anaheim, CA. The meeting was attended by more than 25,000 pharmacists and is widely known in the pharmacy community as the largest professional gathering of pharmacists in the world.
ASBM was represented at the Midyear Meeting by its Advisory Board Chair, Philip Schneider, MS, FASHP, FFIP; who is a past president of ASHP.
At ASBM’s booth, Schneider and ASBM staff distributed information to attendees regarding key biosimilar policy issues which affect pharmacy practice. These include biosimilar approval, biosimilar naming, substitution policy at the state level, and the non-medical switching of patients’ biologic medicines by payers.
Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and fellow ASBM Advisory Board member Ron Jordan, Dean of the Chapman University College of Pharmacy and past president of the American Pharmacist Association (APhA).
ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.
Read more about the ASHP Midyear Meeting here.
November-December 2018 Newsletter
December 1, 2018
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GaBI Journal: Benefits of WHO’s BQ Proposal to Middle Eastern Countries; co-authored by ASBM’s Michael Reilly
November 14, 2018
On November 2nd, 2018, the GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier”.
The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would bring to Middle Eastern countries if and when it were to be made available. From the abstract:
When it comes to monitoring the quality, safety and efficacy of biological medicines, distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biological medicines. Since no biosimilar is perfectly identical to its innovator parent, every biological – whether reference product or biosimilar – must be fully distinguishable from other biologicals to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming of all biologicals will improve patient safety by reducing confusion and mishaps in prescribing and holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologicals including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.The World Health Organization (WHO) must finalize their Biologic Qualifier guidance. It is this organization that has the responsibility to ensure that developing nations of the world have access to affordable, quality medicines. Safety is mission critical and the Biological Qualifier is a potent tool on behalf of global public health.
Read the full article here.
ASBM Presents at 67th WHO INN Consultation
November 6, 2018
On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 66th INN Consultation may be viewed here.
The day prior to the INN Consultation, ASBM released a whitepaper on an April 11 meeting on Harmonization of Biologic Nomenclature sponsored by ASBM and Scientific American. That meeting and the resulting whitepaper revealed strong stakeholder support both for distinct naming and for international harmonization of naming systems; participants agreed that WHO involvement was necessary to advance these aims. The meeting included representatives from FDA, Health Canada, physician societies, pharmacists, and patient advocacy organizations. A follow-up meeting was held on July 12th at which support for distinct naming, international harmonization of nomenclature, and WHO leadership were reiterated.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
October 2018 Newsletter
November 1, 2018
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Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now
October 22, 2018
Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now
A whitepaper released today by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe. Names – of products, people, places – are important in many settings but perhaps nowhere more important than in the medical arena where confusion could be dangerous. Harmonization of naming practices for biologic medicines is seen as essential for maintaining a safe supply of biologic medicines. Regulators and physicians believe WHO is best positioned to lead this effort.
Biologic medicines have revolutionized the treatment of many chronic illnesses and less expensive versions of these important medicines are becoming available. However, because biologics are made using living cells, no two products from different manufacturers will be the same. Distinguishable names for biologics made by different manufacturers enable doctors to prescribe, pharmacists to dispense and regulators to track biologics with specificity.
According to the newly released paper, regulators, physicians, and patients are supportive of international harmonization of biologic names and are calling on the WHO to implement the proposed naming system so that it is available for regulators to use.
The paper is based on a roundtable discussion on international harmonization of biologic nomenclature held April 11th in Washington DC. Participants included representatives from the U.S. FDA and Health Canada, major physician and pharmacist societies, and patient advocates. The forum was sponsored by the Alliance for Safe Biologic Medicines (ASBM) and Scientific American, which prepared the paper.
The World Health Organization has examined biologic naming extensively. In 2014, the WHO’s Expert Group responsible for medicine naming recommended the WHO implement a voluntary international standard of naming for all biologics using a “biologic qualifier” or BQ. The BQ is a four-letter suffix that would be appended to the root scientific name – the International Nonproprietary Name (INN) – assigned by WHO. Biologic medicines with a certain level of similarity would have the same INN so the BQ would distinguish each biologic by a different manufacturer, thus enabling regulators to attribute any problems to the exact product. This is important due to the very sensitive nature of biologics and the risk of an unwanted immune response by patients.
Despite wide support for the BQ proposal outside of WHO as well – regulators support it by a 2-to-1 margin as do large majorities of surveyed physicians in the US (66%) and Canada (68%) Australia (79%) and in Latin America (94%) – WHO has not yet implemented the system its expert committee recommended.
In the absence of action by WHO, regulators around the world have begun to act independently. The FDA implemented its own BQ-like naming system in 2015, and Japan has adopted a different distinct suffix system. Canada is looking for global harmonization but considering a regional approach as an alternative. If not reconciled soon, the divergent naming practices could make prescribing, dispensing and tracking difficult in a global economy and impede access to these life-saving medicines.
“A regulator’s job is not confined to the corners of their geography,” says Anthony Ridgway, acting director of the Centre for Evaluation of Radiopharmaceutical and Biotherapeutics at Health Canada, who participated in the forum. Continued lack of clarity globally makes identification and association of adverse reactions across jurisdictions, and resolution of problems, more difficult. A harmonized international naming standard would help patients who fill prescriptions while travelling internationally, for example.
The BQ’s benefits might be felt most by lower- and middle- income countries without their own robust pharmacovigilance systems. “The WHO is indispensable in building a global system of pharmacovigilance for biologics,” says Michael Reilly, ASBM’s executive director.
ASBM released the paper simultaneously at the WHO’s 67th International Consultation on Nonproprietary Names, in Geneva, Switzerland; and at the 2018 Annual Meeting of the American College of Rheumatology in Chicago, IL. The paper is also available here.
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