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.
March 18th, 2014
Brussels — Today, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in Q3 of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, endocrinology and oncology. The results were released at a stakeholder roundtable hosted by EuropaBio, with representatives from physicians and patient groups, as well as industry and regulatory bodies.
One of the main findings of the survey relates to European physicians’ insufficient knowledge of biosimilars. Only 22% consider themselves as very familiar with this new category of medicines. Whilst a majority (54%) have a basic understanding of biosimilars 24% of participants cannot define or have not heard about biosimilars before.
The findings stress that using the same International Non-Proprietary Name (INN) for two medicines (innovator biologic and biosimilar) can be misleading. Firstly, this may lead to false attribution of adverse event if reporters only report the INN, but also it may give the wrong impression that these medicines are structurally identical (54% of those surveyed thought that the same INN meant the products were structurally identical).
Although the results showed that physicians prefer to use brand names when prescribing biological medicines and reporting adverse events, the findings around the use of INN and its meaning in the context of biosimilar products lead us to conclude that the use of distinguishable INN for all biologics, including biosimilars, is critical to further strengthen and facilitate patient safety through effective pharmacovigilance.
The survey also provides important information regarding substitution. 72% of prescribers consider it “Critical” or “Very Important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar. As a consequence, 74% consider it “Critical” or “Very Important” that the mention of “Dispense as Written” on prescriptions should be respected, and 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of treatment.
Michael Reilly, Executive Director of the ASBM, commented, “The ASBM survey is the first large-scale survey on biosimilars in Europe. It reflects the daily clinical practice with regards to biologic medicines including biosimilars, and provides facts and figures that put current international, EU as well as national policy developments in the field of naming and substitution into perspective.” He also added that key findings of the survey show that 54% of physicians surveyed only have a basic understanding of biosimilars, and more concerning that 24% cannot define or have not heard about biosimilars before.”
Nathalie Moll, Secretary General of EuropaBio, added, “The results of the survey indicate that the understanding of biosimilars is not yet wide-spread among physicians. At the same time, doctors need to be fully aware of the characteristics of biologics and biosimilars to be in a position to prescribe the medicine that will maximise patient outcomes. In the coming months, EuropaBio shall commit to raising awareness, through an open dialogue with physicians and regulators, which will include workshops at member state level.”
EuropaBio is the European Association of BioIndustries. Our members are involved in research, development, testing, manufacturing and commercialisation of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership who in turn represent more than 1800 biotech SMEs.
March 6th, 2014
On February 25, ASBM held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars.
The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and Emerging Challenges” focused on the challenges facing world regulators including the U.S. Food and Drug Administration (FDA), the importance of distinguishable non-proprietary names for biosimilars and the value of and need for patient, physician and pharmacist education on issues related to biosimilars.
INTRODUCTORY VIDEO ON BIOSIMILARS
Following opening remarks by ASBM Chairman Richard Dolinar, MD, this seven-minute video was shown, setting the stage for the day’s presentations and panels by answering some fundamental questions about biologic medicines: What are biologics? How do they help patients? How do they differ from chemical drugs? What are biosimilars? And what unique challenges do they present for regulators and policymakers?
PRESENTATION: ASBM ACTIVITY, 2011-2014
Michael S. Reilly, ASBM Executive Director
ASBM Executive Director Michael S. Reilly reviews the regulatory history of biosimilars in the U.S., beginning with the Affordable Care Act’s creation of a biosimilar pathway, and the formation of ASBM in late 2010 as a means of offering guidance to FDA from a diverse group of patients, physicians, researchers, and industry stakeholders. Mr. Reilly outlines major projects of ASBM over the past few years and tracks its evolution from a primarily domestic advocacy group, into a voice for global standards governing the safety, efficacy, approval, and naming of biosimilars.
PRESENTATION: THE VALUE OF PATIENT ADVOCACY
Andrew Spiegel, ASBM Steering Committee Member and Co-executive Director of the Global Colon Cancer Association
Mr. Spiegel discusses the value of patient advocacy, highlighting how ASBM has benefitted patients. Mr. Spiegel details his experience as a patient advocate including his work with patient groups around the world, and his advocacy to policymakers throughout the U.S. This presentation set the stage for the subsequent panel discussion featuring Mr. Spiegel, Marcia Horn, President of the International Cancer Advocacy Network, and Joseph Jefferson, Director of Advocacy and Alliance Development at HealthHIV. Brian Rye, Health Policy Analyst at Bloomberg Government, moderated the discussion.
PRESENTATION: REGULATORY CHALLENGES FOR THE FDA
Dirk Reitsma, MD, ASBM Advisory Board Member
As the U.S. biosimilar pathway evolves, FDA continues to develop its guidance for biosimilar manufacturers, including what type of data a manufacturer will need to provide for a biosimilar to be determined as ‘interchangeable’, how clinical trials will need to be designed, and how well-understood the biosimilar’s mechanism of action must be to ensure quality and safety. ASBM International Advisory Board Member and oncology researcher Dirk Reitsma, MD gives a regulatory update and offers his thoughts on how current regulatory regimes in existence around the world may, or may not, impact FDA’s upcoming regulation.
PRESENTATION: DEVELOPING INTERNATIONAL REGULATORY STANDARDS FOR BIOSIMILARS
Kirsten Vadheim, PhD
Approval of any medicine for patient use requires safety and efficacy data over time, to minimize the incidence of adverse events. In this presentation, former FDA regulator Kirsten Vadheim underscores the importance of these high standards for biologics in particular, due to their complexity and extreme sensitivity to minor manufacturing differences. Also examined are the efforts of several organizations around the world, including the World Health Organization (WHO) to build a shared, international framework of regulatory standards for biosimilars.
PANEL DISCUSSION: A COLLABORATIVE APPROACH TO PHARMACOVIGILANCE
Richard Dolinar, MD, ASBM Chairman view presentation
Phil Schneider, Associate Dean, University of Arizona College of Pharmacy view presentation
Under what circumstances may a biosimilar be substituted for its reference biologic, either by a pharmacist, insurer, or another third party? What type of communication and record-keeping must occur between prescriber and pharmacist to ensure good tracking and tracing of adverse events? These are the questions with which many state lawmakers are grappling, as biosimilar substitution legislation is debated across the U.S.
In conjunction with a panel discussion moderated by Brian Rye of Bloomberg Government, ASBM Chairman Richard Dolinar, MD presented the physician’s perspective on biosimilar substitution, along with a brief legislative review and update about an increasingly more collaborative approach to biosimilar legislation.
ASBM International Advisory Board Member and Associate Dean of the University of Arizona College of Pharmacy Phil Schneider in turn offers the pharmacist’s perspective, highlighting the common ground between physician and pharmacist, and areas where communication and cooperation could be improved.