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.
April 2nd, 2014
ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars.
The video includes perspectives from Steve Marmaras of GHLF; Donna Cryer a prominent patient advocate who uses biologics; former FDA official Peter Pitts; as well as ASBM executive director Michael Reilly and RetireSafe president Thair Phillips.
March 25th, 2014
Arlington, VA – Today, the Alliance for Safe Biologic Medicines (ASBM) applauds Governor Mike Pence of Indiana in signing legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the Food and Drug Administration (FDA).
“We commend Indiana in taking the lead to make patient safety the priority as life-altering biologics become more readily available to patients in the United States,” commented Richard Dolinar, M.D. Chairman of ASBM.
Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by maintaining the proper communication between pharmacists and prescribing physicians. Specifically, the new law provides that pharmacist must notify the treating physician within 10 days of the exact biologic product by manufacturer in order to attribute any adverse events that may occur. In addition, the pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. The pharmacists must also make sure the patient is aware of substitutions that occur.
“As a practicing endocrinologist, when it comes to treating patients, I need to know what medicines my patients are taking to properly manage disease,” continued Dolinar. “Without proper communication, I may not be able to address setbacks in treatment or accurately attribute adverse events and may lose valuable treatment time. This law ensures there are procedures in place to facilitate that exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines.”
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Unlike drugs derived from chemicals, biologics are manufactured using a unique process with living cells and for this reason no two biologics made from different cell lines are ever identical. When attempting to replicate biologics, their “copies,” known as biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and are often mistakenly referred to as “generics.” Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.
ASBM has supported the FDA in its mission to safely bring biosimilars to the U.S. and will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety remains the priority.
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 17th, 2014
VP of Advocacy and Public Policy for the Arthritis Foundation, Heartland Region writes in about Illinois Senate Bill. Read more here.
March 1st, 2014
The Alliance for Safe Biologic Medicines submitted comments to the Federal Trade Commission in regards to the “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” hearing held in February. Read comments here.
February 1st, 2014
Opinion piece by Dr. Sol De Jesus in the Lebanon Daily News. Read here.
January 17th, 2014
“The Physician’s Perspective: A health policy brief from the Institute for Patient Access,” discusses the importance of a doctor’s need to know when their patients are switched to a biosimilar –- an issue public policy makers in the states are currently considering.
Read more here.
November 22nd, 2013
Dublin, Ireland – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a new survey on European physicians’ views on biosimilar naming. ASBM Executive Director Michael Reilly presented the findings at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety.
The survey examined responses from more than 470 prescribers located in the United Kingdom, France, Germany, Italy and Spain. The respondents included nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists – all specialties that prescribe biologics.
Key findings from the survey include:
In September 2012, ASBM conducted a similar survey that examined practices and perspectives on biosimilar naming and substitution of over 350 physicians in the U.S. The survey was intended to provide data to help support the U.S. Food and Drug Administration (FDA) as they determine biosimilar policies that will have a fundamental impact on patient safety.
Unlike physicians in the U.S., where biosimilars are not yet available, the perspective of European physicians reflects hands-on clinical experience with biosimilars in a therapeutic setting.
The responses of the European physicians demonstrate the need for distinguishable nonproprietary names to be given for all biologics. Biosimilars, in contrast to generic drugs, may have different structure and therapeutic profile, and be approved for different indications than the reference product.
In his presentation, Reilly noted the commonality of physicians’ views across the ocean despite the significant difference in their respective experience with biosimilars since biosimilars have been on the market in Europe for several years but are not yet approved in the U.S.
“The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking. Identical nonproprietary names are generally understood to mean that the products are both identical and approved for the same indications – incorrect and potentially unsafe assumptions for biologics.
“More and more biologic medicines, both innovative and biosimilar, are being approved around the world. How these products are named will clearly play an important role in facilitating global pharmacovigilance and the safe use of these medicines.”
Both surveys were conducted by Industry Standard Research. European Survey data will be shared in the participating countries following the upcoming holiday season.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
For more information, please contact:
Alliance for Safe Biologic Medicines
November 21st, 2013
Dr. Dolinar discusses biosimilars with Seth Ginsberg of the Global Healthy Living Foundation on WFAS AM 1230 talk radio, Greater NYC. Listen