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 “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:
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 survey’s findings:
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.
March 16th, 2015
With the U.S. Food and Drug Administration’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, “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,” 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 – 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.
“We 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,” 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. “Biosimilars are highly advanced prescription medicines and it’s now more important than ever that we are educating the pharmacist community.”
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, “Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance,” 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 medication’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. 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. 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. 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 presentation 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 presentation 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:
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 “Looking at the Commercial Realities of the Biosimilar Market”. 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. The panel focused on Biosimilar policies and adoption. 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:
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.
June 19th, 2014
On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.
“Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars. Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.
Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars. Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.
View presentation here.
June 10th, 2014
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars”, a media briefing hosted by AbbVie on June 10th in Paris, France.
The two-part event was webcast worldwide and featured a discussion on the scientific and regulatory challenges presented by biologics and biosimilars. Mr. Reilly presented the results of the ASBM EU Physician Survey, and also participated in a panel discussion with ASBM Steering Committee member and Co-Chair of the Global Colon Cancer Association, Andrew Spiegel.
Mr. Reilly’s presentation can be viewed here.
April 23rd, 2014
ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the Biosimilars Price Competition and Innovation Act (BPCIA).
The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.
To view Mr. Reilly’s presentation for the FDLI conference, click here.
April 8th, 2014
Geneva — ASBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines can be misinterpreted by doctors and thus have unintended consequences for patients.
To see ASBM presentation, click here.