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ASBM Meets with White House on Biosimilar Naming

May 21st, 2015

WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars.

In attendance were officials from the White House’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS). ASBM was represented by its Chairman, pediatric rheumatologist Dr. Harry Gewanter; and its Executive Director, Michael S. Reilly.

Mr. Reilly described ASBM’s membership, and activities, and Dr. Gewanter provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.

Dr. Gewanter praised the FDA’s use of distinguishable naming in its first biosimilar approval of Zarxio (filgrastim-sndz), calling the differentiating suffix “helpful”. Dr. Gewanter noted its similarity to the World Health Organization’s (WHO’s) own proposal for distinguishable naming, the Biological Qualifier (BQ)-in which a biosimilar’s International Nonproprietary Name (INN) would consist of a suffix of random letters appended to the INN of its reference product. Gewanter, who recently participated in the WHO’s 60th Consultation on International Nonproprietary Names in April, praised the WHO’s international approach to clear naming: “We need a clear label and INN is a good choice because the issue is a global issue.”

Mr. Reilly echoed the need to find a global, rather than local, solution to the issue of biosimilar naming, praising the WHO’s approach and emphasizing that transparency in naming was key to successfully building physician confidence in biosimilars.

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Letters to FDA Praise Use of Distinguishable Biosimilar Naming, Urge Greater Label Transparency

May 13th, 2015

On May 6, ASBM Chairman Harry Gewanter, M.D., sent a letter to Acting FDA Commissioner Stephen Ostroff, M.D, sharing ASBM’s recent survey on labeling and raising some concerns on the same issue.

Dr. Gewanter pointed out that the labeling for the recently approved biosimilar, Zarxio, falls short with the FDA’s longstanding emphasis on transparency and that clinically important product information is absent from the label. Dr. Gewanter said it is essential that the FDA include clear, appropriate and specific product labeling so patients and their healthcare team can make the best and most informed therapeutic decisions possible.

Read the letter here.

Physicians are not the only ones concerned with biosimilar labeling. On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in continuing education class with ASBM – also sent a letter to Stephen Ostroff expressing concerns. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and in the letter the pharmacists urged the FDA to consider a requirement for more informative labeling.

Read the letter here.

Pharmacist Letter to FDA on Labeling

May 3rd, 2015

On April 23, Philip Schneider, University of Arizona College of Pharmacy professor, Ronald P. Jordan, Chapman University School of Pharmacy Dean and Joseph J. Bova, Director of Continuing Education at the Long Island University College of Pharmacy, sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug, on their concerns on biosimilar labeling. Jordan is former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and together the three pharmacists urged the FDA to consider a requirement for more informative labeling of biosimilars.

Read the letter here.

 

GaBI: Physicians’ views on biosimilars labelling

April 20th, 2015

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients’ [1].

The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.

Read the full article here.

ASBM Presents at 60th WHO Naming Meeting

April 14th, 2015

Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.

This stakeholder session was the second time Dr. Gewanter was given the privilege to present and it was ASBM’s fourth time attending. ASBM was especially pleased that Dr. Schneider presented with Dr. Gewanter and was able to provide a pharmacist’s view on the topic of naming.

“We are so grateful for the opportunity to present at the WHO,” said Dr. Gewanter in his opening remarks. “Biosimilars’ high sensitivity to manufacturing differences, light, heat, denaturing; and their potential to stimulate unwanted immune reactions, means clear product identification is essential. ASBM believes that information, cooperation, communication and collaboration are vital to ensuring the best outcomes for patients across the globe. Implementing the WHO’s BQ proposal will make patient safety a priority.”
Dr. Schneider agreed that the BQ proposal would help ensure safety through clear product identification.

“All medicines, regardless of their similarity, should be easily identifiable,” said Dr. Schneider. “The pharmacy community has long advocated that drug names be clear to help avoid confusion and errors – and this could not be more true when it comes to highly complex biologic medicines. They must be easily distinguishable from each other and from other medicines. It is our hope that regulators around the world, including the FDA and EMA, adopt the BQ proposal by the WHO INN Programme, and its application within their jurisdictions.”

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 of last year, 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.

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

Podcast on FDA Biosimilar Approval

April 12th, 2015

Nigel Rulewski, MD, Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discusses the historic step the U.S. Food and Drug Administration (FDA) took on March 6, 2015 approving the first ever biosimilar product for the U.S. market.

Listen to the podcast here.

The Pew Charitable Trusts: More States Demand Notification to Use Biosimilar Drugs

April 5th, 2015

Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.

Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.

Read full article here.

New ASBM Survey Provides Physicians’ Views on Biosimilar Labeling

March 23rd, 2015

Timely survey released as FDA approves first biosimilar

The Alliance for Safe Biologic Medicines today released the results from a survey on physicians’ priorities related to biosimilar labeling. ASBM first shared the key survey findings at the “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. The survey reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.

A strong consensus was apparent among the four hundred physicians surveyed, all of whom are board-certified, practice in the U.S. and prescribe biologic medicines. They include dermatologists, endocrinologists, oncologists, nephrologists, neurologists and rheumatologists. ASBM Executive Director Michael Reilly presented at the autoimmune summit and discussed the role biotech medicines play in treating autoimmune diseases. His presentation addressed the recent approval of the first biosimilar medicine in the U.S. and the timeliness of the new survey data as FDA considers the multiple biosimilar applications said to be pending before the agency.

“ASBM commends the FDA for their work to make biosimilars a reality for patients across the country,” said Reilly. “We believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines. The survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.”

In the survey, participants were asked to rank the importance to the following questions on a five- point scale, with five being the highest:

  • How important is it that a product label for a biosimilar clearly indicates that it is a biosimilar? 90% of respondents rate the importance as a 4 or 5.
  • How important is it that the biosimilar label includes the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product? 82% rate the importance as a 4 or a 5.
  • How important is it that the biosimilar label includes the clinical data, if any, submitted to FDA by the biosimilar sponsor to demonstrate that it is highly similar to the reference product? 83% rate the importance as a 4 or 5.
  • How important is it that the label explicitly states that specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product? 79% rate the importance as a 4 or 5.

ASBM has conducted surveys on physicians’ understanding of and views about biologics and biosimilars in the U.S., in Europe and in Canada, with the goal of providing to regulators the information needed to help advance the success and safe use of biologic medicines around the world.

View the survey here.

View the one pager here.

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.

ASBM Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16th, 2015

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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.


View the March 15 Pharmacist Continuing Education Presentations Below: 

Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Impact
Presented by 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

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In this presentation, Dr. Schneider outlines a brief history of biologic medicines, how they differ from traditional chemical medicines, identifies concerns about their sensitivity during manufacturing, handling and preparation. The concept of biosimilarity is explored and the issues of interchangeability and naming are introduced. View the presentation here.

 

Biologics and Biosimilars: The Patient Perspective
Presented by Andrew Spiegel, Esq.,
Executive Director, Global Colon Cancer Association; ASBM Steering Committee member

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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
Presented by Harry L. Gewanter, MD, FAAP, FACR,
Pediatric Rheumatologist; Chairman, Alliance for Safe Biologic Medicines

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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
Presented by Bruce Babbitt, PhD,
Principal Consultant, PAREXEL Consulting

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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
Presented by 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

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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.

 


Preparing for Biosimilars: The Evolving Role of Pharmacists in the Age of Biologic Therapies
Presented by Ronald P. Jordan, BPharm, RPh, FAPhA,
Dean, Chapman University School of Pharmacy

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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.

 

Denver Business Journal: Biosimilars bill approved by Colorado Legislature

March 11th, 2015

Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law.

The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk.

Read full story here.