April 1st, 2016
ConferenceÂ Shows StrongÂ Support for Distinct Names, Meaningful Suffixes for Biologics Among Pharmacists
NEWPORT, RI â€” On March 31st, the Alliance for Safe Biologic Medicines (ASBM) gave an educational presentation on biologics and biosimilars for 150Â pharmacists attending the 31st annual Seminar by the Sea conference, held by the University of Rhode Island College of Pharmacy.
ASBM Advisory Board Chair Philip Schneider, Associate Dean at the University of Arizona College of Pharmacy, gave the 45-minute presentation. Dr. Schneider explained the basic science of biologic medicines, the differences between biosimilars and generic medicines, and how these differences pose new regulatory challenges for healthcare providers including pharmacists.
Unlike generic drugs, biosimilars are not exact copies of the medicines on which they are based, and some of these differences can create unexpected effects in patients, including unwanted immune responses. Dr. Schneider emphasized the need for clear product identification when dealing with biologics and biosimilars:
â€œPharmacists have traditionally avoided look-alike and sound-alike drug names. Both the World Health Organization (WHO) and Food and Drug Administration (FDA) have proposed systems that use differentiating four-letter suffixes to provide distinct naming for all biologics, including biosimilars. This allows accurate tracking of patient response and of the long-term safety and efficacy of these agents.â€
Dr. Schneider noted that national pharmacist societies including the American Pharmacists Association (APhA) and the American Society of Health-system Pharmacists (ASHP), of which Dr. Schneider is a past president, have traditionally opposed distinct naming. Yet while these societies prefer to rely on National Drug Codes (NDCs) to differentiate between similar medicines, rank and file pharmacists are significantly more receptive to the idea of distinct names:
â€œASBM found that when we asked pharmacists at our Continuing Education courses, most considered the value of clear product identification with biologics very important or critical. This led us to examine and quantify these perspectives with a survey of 401 U.S. pharmacists. That survey revealed that 68% support the FDA issuing distinct names.â€
A poll taken during the speech revealed that of about 150 pharmacists in the audience, an astonishing 97% supported distinct names:
Regulators are still discussing how best to design a differentiating suffix. The FDAâ€™s first approval, for Zarxio (filgrastim-sndz), used a meaningful suffix â€œ-sndzâ€ reflecting the name of its manufacturer, Sandoz. But the WHO and FDA are both soliciting feedback on proposals to instead use random suffixes, which carry no meaning.
ASBMâ€™s survey revealed that 77% of pharmacists prefer a suffix based on the manufacturer name, with only 15% preferring random suffixes. Similarly, the audience poll showed 77% supporting manufacturer-based suffixes, and 21% preferring random suffixes:
Dr. Schneiderâ€™s presentation also addressed the issue of biosimilar labeling– including what information is available to providers on the product insert.
Dr. Schneider emphasized that pharmacists want more information and greater transparency than the FDA currently requires. For example, 81% considered it important for the product to state that it is a biosimilar; 69% considered it important to clearly distinguish data generated by the biosimilar from data generated by the originator product; and 88% considered it important to state whether or not the biosimilar is interchangeable with its reference product.
Later that day, the FDA would release its long-awaited Draft Guidance on Labeling, which begins to address some, though not all, of the respondentsâ€™ concerns. For example, while it would identify the product as being biosimilar, it would not distinguish which product- the reference or the biosimilar- generated the safety and efficacy data on the biosimilar label. It also does not address whether the biosimilar is or is not interchangeable with its reference product.
Finally, Dr. Schneider discussed the issue of biosimilar substitution at the state level, including what communication should occur between pharmacist and physician following a substitution:
â€œCollaboration and communication between pharmacists and physicians is critical to providing effective care. Everyone should know which medicine the patient actually receives, so we can make informed assessments of a patientâ€™s response to a particular treatment.â€
Since 2013, 19 states and Puerto Rico have enacted laws which permit pharmacists to substitute biosimilars, provided they communicate to the prescribing physician within a 5-to10-day timeframe which product was dispensed.
The full ASBM Pharmacist Survey results may be read here.
March 25th, 2016
On March 24th, in Louisville, KY, ASBM presented a one hour program entitled “Biosimilars: New Choices, New Challenges”, on the benefits and challengesÂ which will accompany the arrival of biosimilars to the U.S. healthcare landscape. The event was held at the University of Louisvilleâ€™s Kosair Charities Clinical & Translational Research Facility, and the audience consisted of patients, physicians, medical students, and other health professionals.
The first presentation, by Chairman Harry L. Gewanter, MD focused on the perspectives of healthcare providers such as physicians who prescribe biosimilars and pharmacists who dispense them. Dr. Gewanter shared survey data which showed strong support among these groups for distinguishable naming of biosimilars. Also important was informative, transparent labeling that helps them provide informed advice to their patients. Dr. Gewanter also emphasized the need for collaboration and communication between providers, particularly in the case of a potential biosimilar substitution.
View Dr. Gewanter’s presentation here.Â
The second presentation was from ASBM Advisory Board Member and Executive Director of the Global Colon Cancer Association, Andrew Spiegel. Mr. Spiegelâ€™s presentation focused on the patientâ€™s perspective on biosimilars.
Mr. Spiegel spoke of his great enthusiasm about the coming of biosimilars, which will increase access to the biologic therapies that are extending and improving the lives of millions of patients. But he also cautioned that governments and insurers are under great cost pressures, and that policymakers must always keep patient safety as their primary focus when approving and regulating biosimilars.
View Mr. Spiegel’s presentation here.Â
March 24th, 2016
On March 23rd, ASBM conducted an hour-long presentations entitled â€œBiosimilars: New Choices, New Challengesâ€ for a group of patients and healthcare providers in St. Louis, MO.The presentation was given at a hospital complex in downtown St. Louis which includes Barnes Jewish Hospital St. Louis Childrenâ€™s Hospital and Shrinerâ€™s Hospital for Children.
The program began with ASBM Chairman Harry L. Gewanter, MD outlining for attendees the basic science of biologics and biosimilars, including the differences between biosimilars and chemical generics. Dr. Gewanter then provided a physicianâ€™s perspective on issues such as the need for distinguishable naming of biologics, and the need for pharmacist-physician communication in the event of a biosimilar substitution.
Following Dr. Gewanter was ASBM Advisory Board Chair, University of Arizona professor of pharmacy Philip Schneider, who provided a pharmacist perspective on biosimilars. Dr. Schneider also emphasized clear product identification as critical for biologics, including biosimilars, referencing survey data showing support among pharmacists for distinct names. Dr. Schneider also examined the issue of biosimilar labeling, citing survey data that show many providers want more transparent and informative labeling than is currently required by the FDA. Finally, he outlined how many states, including Missouri, are crafting biosimilar substitution legislation that addresses the need for physician-pharmacist communication.
The final presentation was from ASBM Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, who provided a patientâ€™s perspective. Mr. Spiegel expressed optimism about the new choices and lower costs biosimilars will provide. Yet he stressed the need to maintain transparency in their approval process, and to keep treatment decisions- including the decision to switch- the purview of physician and patient rather than a third party.
August 1st, 2015
On July 31, in Bend, Oregon, ASBM conducted a continuing education (CE) course for physicians, pharmacists, nurses, and other healthcare providers at six hospitals in the St. Charles Health System. Headquartered inÂ Bend, Oregon, the system owns and operates St. Charles Madras, St. Charles Redmond, Pioneer Memorial Hospital, Blue Mountain Hospital, Lake District Hospital, and Harney District Hospital. The health system employs more than 3,000 people.
The course, entitled â€œBiosimilars: What Every Physician and Pharmacist Needs to Knowâ€ was presented by ASBM Executive Director Michael Reilly, and covered the definition of biologics and biosimilars, the difference between biosimilars and generic chemical drugs for purposes of patient care, associated regulatory challenges, and the importance of physician-pharmacist communication and cooperation.
â€œBiologic medicines are among the most powerful therapeutic tools healthcare providers have at their disposal to treat patients with serious conditions like rheumatoid arthritis and colorectal cancer,â€ said Reilly. â€œBiosimilars will soon provide them with new therapeutic options, potentially at reduced cost to their patients- but they also bring new challengesâ€¦ learning about them is critical to providing quality care.â€
Mr. Reillyâ€™s presentation may be viewed here.
The 1-hour CE course was accredited by the Oregon Medical Association, the American Academy of Family Physicians, the Oregon Board of Pharmacy, and the California Board of Registered Nursing.
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 â€œBIOSIMILARS: WHAT EVERY PHARMACIST SHOULD KNOWâ€ at Chapmanâ€™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 ASBMâ€™s activities serving as a resource for physician, patient and pharmacist perspectives for regulators in the U.S. and internationally. View his presentationÂ 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 ofÂ 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 presentationÂ here.
ASBM chairman Dr. Harry Gewanter then shared survey data reflecting physicians views on the importance of transparency in medicines, including the value of distinguishableÂ 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 alsoÂ stressed the need for timely physician-physician communication in cases of biosimilar substitution. View his presentationÂ here.
Finally, Dr. Schneider discussed the evolution and current status of biosimilar substitution legislation in the U.S. He stressedÂ theÂ common ground between physicians and pharmacists, and value of cooperation and collaboration with physicians for general purposes of patient safety and pharmacovigilance. Â View his presentationÂ here.
Following the course, an informal survey was conducted to measure the participantsâ€™ attitudes toward biosimilar naming. The results showed that the pharmacists in attendance were extremely supportive of distinguishable naming:
- When asked â€œAs a pharmacist, how important is it for me to be able to clearly distinguish between two similar biologic medicines?â€ 90% of respondents replied â€œVery Important or Criticalâ€.
- When presented with the statement â€œA biosimilar should have a name that allows it to be clearly distinguishable from the innovator or reference product to which it is similar.â€ 93% agreed with this statement.
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 surveyâ€™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. Gewanterâ€™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 Europeâ€™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 processÂ 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.
March 16th, 2015
|With the U.S. Food and Drug Administrationâ€™s (FDA) announcement of the first biosimilar approval, on March 15th, the Alliance for Safe Biologic Medicines (ASBM) held a five-hour class offered through the Long Island University (LIU Pharmacy) to educate pharmacists on the fundamentals of these breakthrough new medicines. The continuing education (CE) class, â€œThe Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,â€ was held at the New York LaGuardia Airport Marriott and explained what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them.The class discussed the basic science and manufacturing of biologic medicines; the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs; their difference from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice; and the important regulatory and policy considerations â€” that many state capitals are currently legislating across the country.Speakers throughout the day stressed the need to ensure patient safety and the importance of physicians and pharmacists working together to ensure that safety. ASBM Chairman and pediatric rheumatologist, Dr. Harry Gewanter and Global Colon Cancer Association Executive Director Andrew Spiegel provided a physician and patient perspective and Bruce Babbitt, PhD, Principal Consultant, PAREXEL Consulting gave a regulatory overview for the students taking the CE class. Ronald P. Jordan, BPharm, RPh, FAPhA, Dean, Chapman University School of Pharmacy spoke on the importance of the evolving role of pharmacists as biosimilars are approved.
â€œWe are pleased to have ASBM come to New York and give a thorough overview of such an important class of medicines. This is especially timely, given that the FDA just approved the very first biosimilar for U.S. patients two weeks ago,â€ said Joseph J. Bova, M.S., R.PhI, Director of Continuing Professional Education, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University (LIU-Pharmacy), who gave opening remarks. â€œBiosimilars are highly advanced prescription medicines and itâ€™s now more important than ever that we are educating the pharmacist community.â€
In his presentation, 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, focused on the critical importance of communication and the need for physicians and pharmacists to work together. In his presentation, â€œBiosimilar Substitution: A Collaborative Approach to Pharmacovigilance,â€ he said that working in collaboration with physicians and notifying them if a patient receives a different medicine than what was prescribed, will create a stronger track and trace system where the medicationâ€™s efficacy can be assessed and proper attribution will be ensured in the case of an adverse event. He also stressed the importance of continued education for pharmacists, physicians and patients for these lifesaving medicines.
ASBM hopes this is the first of many forums to work with the pharmacist community to ensure patient safety.
Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Impact
Biologics and Biosimilars: The Patient Perspective
In this presentation, patient advocate Andrew Spiegel examines the value of biologics and biosimilars in extending and improving the lives of patients around the world who suffer from serious conditions such as cancer. Mr. Spiegel explains the importance to patients of increased access to biosimilars, and of good communication and collaboration between their pharmacist and physician in regards to biosimilar substitutions, and use of distinguishable naming. Â View this presentation here.
Clinical Perspectives on Biologic Medicines
Drawing from three years of prescriber surveys conducted by ASBM in seven countries, Dr. Gewanter shares physician perspectives on biosimilar naming and substitution. Emerging issues in biosimilar naming are discussed, including FDA approval of the first U.S. biosimilar, and ASBM’s work with the World Health Organization to develop global naming standards. Â Physician-pharmacist cooperation is emphasized as key to good pharmacovigilance. View this presentation here.
Biosimilars: Regulatory and Drug Development
Biologics regulatory expert Bruce Babbitt provides a detailed explanation of the development process for biologic medicines, with an emphasis on trial design and what type of data is required to demonstrate safety. Â How biosimilarity is demonstrated in Europe and Canada is discussed, as is FDA’s current and upcoming guidance. FDA’s first biosimilar approval is discussed, and updates are given on several other biosimilars in the FDA approval pipeline. View this presentationÂ here.
Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Professor Schneider discusses how different U.S. states are approaching the question of determining under what circumstances a pharmacist can substitute an interchangeable biosimilar in place of a prescribed biologic, and what type of information must be recorded. An overview of recent legislation is provided and compared with approaches in Europe and Canada. The importance of pharmacist-physician collaboration in answering these policy questions is emphasized. View this presentation here.
Dean Ronald P. Jordan examines the changing roles and responsibilities of the pharmacist, and how biologic medicines offer increased opportunities for engagement and collaboration among patient, physician and pharmacist. The value of this cooperation is examined in terms of improving quality of care, reducing medication errors, and controlling costs. View Dean Jordan’s presentationÂ here.
December 7th, 2014
On December 2, Executive Director Michael Reilly presented the results from the European physicians survey at the DIA Biosimilars Conference in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars and ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. The German-specific responses had not been uniquely presented this way until the conference.
In his presentation, Mr. Reilly pointed out:
- Only 39% of German physicians responded that they are very familiar with biologic medicines, and only 21% responded they are very familiar with biosimilars.
- 68% surveyed said that if two medicines have the same non-proprietary scientific name, that it suggests or implies that the medicines are structurally identical.
- 40% identify a biologic medicine for prescription or recording in a patient record by identifying the medicine by brand name.
- 62% said it would not be acceptable for a pharmacist to determine which biologic (innovator or biosimilar) to dispense to their patient on initiation of treatment.
The ASBM survey, conducted at the end of 2013, is the first of its kind in Europe. Over 470 nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists from Italy, Spain, France, Germany and the U.K. were surveyed to learn more about their views and understanding of biosimilars. The DIA Conference was the first time German specific data was singled out and compared to the responses of physicians in the four other countries.
View the presentation here.
November 5th, 2014
BOSTON, Massachusetts- On October 20-22, 2014, ASBM members John Lewis and Andrew Spiegel attended the 15th Annual Business of Biosimilars Conference held at the Omni Park Hotel in Boston.
On day one of the conference, John Lewis from ACRO moderated a panel titled â€œLooking at the Commercial Realities of the Biosimilar Marketâ€. Topics discussed included how many companies the market can truly bear, what is it going to take to be successful after overcoming the hurdles of development, accounting for the patient/provider/payer perspectives, and educated attendees on how to make choices about the next MaBs in pipeline. Panelists included: Carsten Brockmeyer, CEO, Formycon AG; Mohammed Ladha, Global Biologics Marketing, Hospira, and Yariv Hefez; Vice President Business Development, Portfolio Management Strategy and Partnering, Biosimilars Unit, Merck Serono.
On the 2nd day of the conference, Andrew Spiegel from the Global Colon Cancer Association joined an expert panel including Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc. and Michael Malecki, Director, (Biosimilars) Research and Development Policy, Amgen.Â The panel focused on Biosimilar policies and adoption.Â Issues discussed included an update on State substitution laws & interchangeability, naming and whether data, reimbursement, cost, payor controls or other factors will drive the adoption of Biosimilars.
October 9th, 2014
ASBM has traveled to cities around the world to participate in regulatory discussions on how to best achieve global safety standards for biosimilars. In August 2014, ASBM representatives took part in several meetings in Rio de Janeiro, Brazil for two different conferences.
ASBM Chairman Dr. Harry Gewanter was a guest speaker at the August 13 “4th Latin America Forum on Biosimilars” where he gave a presentation on interchangeability. He explained the current legislative landscape in the U.S. and highlighted that:
- It is important to physicians that they retain the authority to use “do not substitute” to ensure the patient receives their chosen medicine
- It is important to physicians that they are informed in a timely fashion of the medicine(s) the patient receives and if it is different than what they prescribed
- Distinguishable INNs are important to the practicing physicians in the U.S. and Europe
View his presentation here.
Ten days later, Global Colon Cancer Association Executive Director, Andrew Spiegel participated in the International Alliance of Patients’ Organizations (IAPO) “Increasing the Patient voice in drug regulatory Authorities” meeting in Rio de Janeiro and then presented at the “Pre-International Conference of Drug Regulatory Authorities” on August 24. In his presentation, Spiegel highlighted the need for distinguishable nonproprietary names as a means of keeping patients safe. He urged support for the WHO BQ proposal, which lays the groundwork for creating consistent global policies on naming.
View his presentation here.