Join Us

Mission Statement Image

Press Releases

ASBM Presents at WHO Meeting on Naming

October 17th, 2014


Introduces Chairman Gewanter, shows support for BQ proposal

Geneva – The Alliance for Safe Biologic Medicines (ASBM) presented at the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session on Tuesday, October 14, 2014. This was the third time ASBM presented to the WHO but the first appearance for ASBM’s new chairman Dr. Harry L. Gewanter.

As a practicing pediatric rheumatologist and ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR has been integrally involved in developing policy recommendations involving biosimilars that are patient-focused and physician friendly.

During his presentation “Global Biosimilar Naming Standards: Physician (and Patient) Perspectives” Dr. Gewanter thanked the WHO for the opportunity to present and for its efforts to prioritize patient safety.

At the request of the WHO, the proceedings of the stakeholder session are to remain confidential until the esteemed body has an opportunity to hold a closed session to discuss the “Biological Qualifier” proposal that was released in August.

ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.

In the U.S., ASBM has encouraged the FDA to follow the WHO’s lead. In August, ASBM and over 70 patient organizations wrote a letter encouraging the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming in a timely manner as the first application for a biosimilar has been accepted.

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:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org

ASBM Names Harry L. Gewanter, MD as Incoming Chairman; Dean Philip Schneider as International Advisory Board Chair

August 7th, 2014

ARLINGTON, VA – Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM) today announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy will serve as the International Advisory Board Chair. Dr. Schneider has served on the ASBM advisory board since September 2012.

“As a member of our International Advisory Board for three years, Dr. Gewanter has been instrumental in helping to craft ASBM’s policy recommendations and has taken an active role in its policy development and education efforts,” said Reilly. “We are excited for Dr. Gewanter to take a more prominent role within the organization and utilize his expertise to forward ASBM’s mission.”

Dr. Gewanter succeeds outgoing chairman Richard Dolinar, MD, who served as ASBM’s initial chairman since 2011. Dolinar has testified before the U.S. Food and Drug Administration (FDA) and the World Health Organization’s (WHO) International Nonproprietary Naming Consultation, as well as appeared as a global keynote speaker.

“Dr. Dolinar oversaw the creation, growth and maturation of ASBM — from an organization focused on shaping the biosimilar approval pathway in the United States to an internationally recognized voice that speaks for patient’s with serious chronic illnesses and the physicians who care for them,” said Dr. Gewanter. “During his tenure, Dr. Dolinar has assisted regulatory bodies as they craft international standards for biosimilars. I look forward to continuing his work as chairman and elevating the voice of patients and physicians in global regulatory decisions to provide patients and physicians additional safe and effective treatment options and greater transparency as biosimilars enter the marketplace.”

“Dr. Dolinar has been an outstanding leader in the education of physicians, patients and policymakers alike in the relatively new arena of biologics and biosimilars,” stated Reilly. “Under his leadership, our membership and impact has grown and we are grateful for his guidance of ASBM.”

Philip Schneider, will also serve ASBM in a new capacity as IAB Chair. During his tenure on ASBM’s Advisory Board, Dr. Schneider has helped educate policymakers on the importance of developing biosimilar policies that encourage collaboration between pharmacists and physicians.

“Pharmacists have an important role to play in the discussion of how biosimilars are treated and we are also the linchpin between patients and the medicines they take, ” stated Schneider. “I look forward to ensuring the pharmacy setting is equipped with the regulations needed to both ensure the safe administration of biosimilars, as well as provide access to potentially lower-cost alternatives to patients.”

Dr. Gewanter and Dr. Schneider will continue ASBM’s global advocacy for policies aimed at ensuring that patients worldwide receive the biologic they were prescribed, that biosimilars are held to high standards of safety and efficacy, and that these medicines can be reliably tracked for adverse events. Gewanter and Schneider will assume their positions on September 1.

###

 

Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars

June 24th, 2014

Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA).  The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.

As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM).  Unlike chemical drugs, biologics are complex medicines treating complicated conditions.  For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients.  I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”

Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015.  While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.

This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’.  The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician.  Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing.  The pharmacy will be required to maintain a record of each substitution for a period of at least a year.

Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars.  This creates a model for other states to follow in order to  address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.

“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar.  We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”

# # #

 

Indiana Governor Signs Biosimilars Legislation Ensuring Patient Safety

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.

###

ASBM Presents New European Survey Findings on Biosimilars and the Importance of Nonproprietary Naming

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:

  • 53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
  • 61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
  • 24% of reporting physicians record only the non-proprietary name of the biological product in the patient record

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:

Michael Reilly

Executive Director

Alliance for Safe Biologic Medicines

Phone: 202-222-8326

E: Michael@safebiologics.org

ASBM Presents at WHO Meeting on Naming in Geneva

October 22nd, 2013

ASBM Presents at WHO Meeting on Naming in Geneva
Calls for Distinct Non-Proprietary Names to Ensure Patient Safety

Geneva, Switzerland - The Alliance for Safe Biologic Medicines (ASBM) today presented at the World Health Organization’s (WHO) 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. During his presentation, ASBM Chairman, Richard Dolinar, M.D., called for the use of distinct non-propriety names for biologic medicines so that it is clear which medicine or medicines a patient received.  Said Dolinar, “It is essential to patient safety that adverse events can be accurately traced back to the correct product.  Distinguishable non-proprietary names for biologic medicines make that more likely.”

For nearly three years, ASBM has been dedicated to ensuring that patient safety is at the forefront of biosimilar policy across the globe as regulatory bodies around the world approve biosimilars for use. ASBM has strongly advocated that all biologics be given distinct non-proprietary names to facilitate accurate attribution of adverse events. The non-proprietary name of a reference product and product/s biosimilar to it, should have a common, shared root but have distinct and differentiating suffixes.  This will enable regulators to hold manufacturers accountable for the quality of their medicines.

Because biologics are made using living cells, as opposed to traditional chemical drugs, they are highly sensitive to the manufacturing process, storage, handling, etc. and small changes in the medicine can have important implications for patients.  ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety.

In his presentation, Dr. Dolinar, a practicing endocrinologist, thanked the WHO for seeking input from the physician and patient communities and urged regulators worldwide to give biosimilars distinguishable names.

“We are grateful for the continued opportunities the WHO has given stakeholders like us to provide input as biosimilar policies are developed,” said Dr. Dolinar. “Product names are a foundational element of communication among health care providers and will have implications for the safe use of biologic medicines.  When we speak about drugs, we need to be very specific. If a patient has an adverse reaction, which can occur months after receiving a biologic medicine, we need to be able to properly identify that medication. Instituting a system of distinguishable names will achieve the common goal of enhancing access to these life-changing therapies, while also protecting the safety of the patients.”

In advance of the WHO meeting, ASBM wrote two letters to WHO regarding the need for instituting a system of distinguishable names.

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

IAPO Mexico City Meeting Includes Discussion on Biosimilars

September 23rd, 2013

On September 23rd, in Mexico City, the International Alliance of Patients’ Organizations (IAPO) hosted a discussion on biosimilars at their Latin American Multi-Stakeholder Seminar.  The meeting was attended by patient and interest groups from the region as well as ASBM Executive Director, Michael Reilly, and Global Colon Cancer Association (GCCA) Co-Executive Director, Andy Spiegel.

The discussion focused on how patient groups can influence biosimilar health policy in Latin American countries, especially Mexico and Columbia, and the need for stringent global regulatory standards that ensure patient safety when it comes to these complex medicines.

ASBM Steering Committee member, GCCA, has officially joined the International Alliance of Patients’ Organizations (IAPO) this year. The Mexico City event served as an opportunity to build on IAPO’s interest in the biosimilars issue following the successful Workshop on Biosimilars Medicines held in Geneva earlier in the year. IAPO is a global alliance of over 200 patients’ organizations representing 50 disease areas and over 60 countries worldwide.

The Alliance for Safe Biologic Medicines Statement on the Need for Unique Names for All Biologic Medicines

September 20th, 2013

WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Importantly, identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify which medicine was actually the root cause, and the patient will suffer.”

Dolinar stressed that unique distinguishable non-proprietary names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. A white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns.

“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar.  “Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.

ASBM called for the use of distinguishable names in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO.  Dr. Dolinar has also presented at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26, 2013 that Dr. Balocco attended. ASBM’s most recent statement was sent to Dr. Margaret Chang, WHO Director-General, on July 31, 2013 in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. ASBM will also be present at that meeting to be held in Geneva on October 22, 2013.

# # #

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

http://safebiologics.org/naming.php

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names at an International Regulator Forum

July 1st, 2013

Ottawa, ONTARIO – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique product names are key to patient safety.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”

Dolinar’s presentation stressed that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. His presentation reviewed findings in a white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” The paper explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns. Dolinar’s presentation in Ottawa followed a presentation earlier in the week at the DIA conference in Boston and furthered the dialogue with the international community towards a consensus among stakeholders on the need for unique names for biosimilars.

“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar. “Cases have occurred wherein a prescribing physician has mistakenly omitted the distinguishing prefix, resulting in a patient receiving the wrong medication, at the wrong dose. Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.

The findings shared were also expressed in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO in Geneva. Dr. Balocco joined Dr. Dolinar and ASBM Executive Director Michael Reilly, along with a hospital pharmacist, and the Chair of the International Alliance for Patient Organizations (IAPO) at the Ottawa forum.

# # #

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27th, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership.

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises across Europe. Its members are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes, and have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.

“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines. “We are pleased to have such an authoritative international partner who brings an experience with biosimilars that does not currently exist in the U.S. We will lean heavily on EuropaBio and its members to better understand the approach taken in the E.U. that has led to the successful introduction of biosimilars.”

In April 2013, the Process on Corporate Responsibility in the field of Pharmaceuticals, spearheaded by Commission Vice-President Antonio Tajani, published its long-awaited report on biosimilars. As members of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure informed and adequate use of these medicines.

The Alliance for Safe Biologic Medicines has had an established International Advisory Board for the purpose of providing ASBM’s Chairman, member organizations, and the general public guidance and expertise as the FDA moves forward to implement a pathway for biosimilar medications. However, the partnership with EuropaBio furthers that mission by serving as an important resource as they evaluate the future of biologics and biosimilars in the United States, Canada, and the EU.

“Countries across the globe have gathered much data which can, at a minimum, help inform our own policy makers,” Executive Director of ASBM, Michael Reilly, stated. “The ASBM will take advantage of the opportunity to learn from their experiences, both positive and negative.”

Miriam Gargesi, Director of Healthcare at EuropaBio added: “We look forward to working with ASBM to continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products. It is therefore necessary that a robust regulatory system and adequate label transparency are in place for all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”

###

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Rosalind Travers
Communications Manager, EuropaBio
Phone: +32 2 739 1173
GSM: +32 (0) 478 680 301
E: r.travers@europabio.org